Trial Outcomes & Findings for Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age (NCT NCT04642079)
NCT ID: NCT04642079
Last Updated: 2024-01-22
Results Overview
Local reactions included redness, swelling and, pain at the injection site, recorded by parent's/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. One measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: \> 0.0 to 2.0 cm, moderate: \>2.0 to 7.0 cm and severe: \>7.0 cm. Pain at the injection site was graded as mild: hurt if gently touched (cohort 1) and did not interfere with activity (cohort 2-4); moderate: hurt if gently touched with crying (cohort 1) and interfered with daily activity (cohort 2-4) and; severe: limited limb movement (cohort 1) and prevented daily activity (cohort 2-4). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
839 participants
Primary outcome timeframe
Within 7 days after vaccination on Day 1
Results posted on
2024-01-22
Participant Flow
A total of 839 participants were enrolled and assigned to receive a single dose of 20-valent pneumococcal conjugate vaccine (20vPnC) of which 8 participants were not vaccinated and 831 were vaccinated with 20vPnC.
Participant milestones
| Measure |
Cohort 1: 20vPnC: >=15 to <24 Months
Participants aged greater than or equal to (\>=) 15 months to less than (\<) 24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 milliliter (mL) 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered greater than (\>) 2 months before enrollment into the study.
|
Cohort 2: 20vPnC: >=2 to <5 Years
Participants aged \>=2 to \<5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 3: 20vPnC: >=5 to <10 Years
Participants aged \>=5 to \<10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
Cohort 4: 20vPnC: >=10 to <18 Years
Participants aged \>=10 to \<18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
210
|
219
|
203
|
207
|
|
Overall Study
Vaccinated
|
209
|
216
|
201
|
205
|
|
Overall Study
COMPLETED
|
207
|
210
|
199
|
203
|
|
Overall Study
NOT COMPLETED
|
3
|
9
|
4
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1: 20vPnC: >=15 to <24 Months
Participants aged greater than or equal to (\>=) 15 months to less than (\<) 24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 milliliter (mL) 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered greater than (\>) 2 months before enrollment into the study.
|
Cohort 2: 20vPnC: >=2 to <5 Years
Participants aged \>=2 to \<5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 3: 20vPnC: >=5 to <10 Years
Participants aged \>=5 to \<10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
Cohort 4: 20vPnC: >=10 to <18 Years
Participants aged \>=10 to \<18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
1
|
2
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
|
Overall Study
No longer met eligibility criteria
|
1
|
0
|
1
|
1
|
Baseline Characteristics
Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age
Baseline characteristics by cohort
| Measure |
Cohort 1: 20vPnC: >=15 to <24 Months
n=210 Participants
Participants aged greater than \>=15 months to \<24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 2: 20vPnC: >=2 to <5 Years
n=219 Participants
Participants aged \>=2 to \<5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 3: 20vPnC: >=5 to <10 Years
n=203 Participants
Participants aged \>=5 to \<10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
Cohort 4: 20vPnC: >=10 to <18 Years
n=207 Participants
Participants aged \>=10 to \<18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
Total
n=839 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
28 Days to 23 Months
|
210 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
210 Participants
n=21 Participants
|
|
Age, Customized
2 Years to 5 Years
|
0 Participants
n=5 Participants
|
219 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
247 Participants
n=21 Participants
|
|
Age, Customized
6 Years to 11 Years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
226 Participants
n=21 Participants
|
|
Age, Customized
12 Years to 18 Years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
156 Participants
n=4 Participants
|
156 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
389 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
450 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
158 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
173 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
676 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
169 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
180 Participants
n=4 Participants
|
700 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after vaccination on Day 1Population: Safety population included all participants who received 20vPnC and had safety follow-up after vaccination. Here, "Number of Participants Analyzed" signifies the number of participants with any electronic diary data after vaccination.
Local reactions included redness, swelling and, pain at the injection site, recorded by parent's/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. One measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: \> 0.0 to 2.0 cm, moderate: \>2.0 to 7.0 cm and severe: \>7.0 cm. Pain at the injection site was graded as mild: hurt if gently touched (cohort 1) and did not interfere with activity (cohort 2-4); moderate: hurt if gently touched with crying (cohort 1) and interfered with daily activity (cohort 2-4) and; severe: limited limb movement (cohort 1) and prevented daily activity (cohort 2-4). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method.
Outcome measures
| Measure |
Cohort 1: 20vPnC: >=15 to <24 Months
n=204 Participants
Participants aged greater than \>=15 months to \<24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 2: 20vPnC: >=2 to <5 Years
n=215 Participants
Participants aged \>=2 to \<5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 3: 20vPnC: >=5 to <10 Years
n=199 Participants
Participants aged \>=5 to \<10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
Cohort 4: 20vPnC: >=10 to <18 Years
n=205 Participants
Participants aged \>=10 to \<18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination
Pain at the injection site: Any
|
52.5 Percentage of participants
Interval 45.4 to 59.5
|
66.0 Percentage of participants
Interval 59.3 to 72.3
|
82.9 Percentage of participants
Interval 77.0 to 87.9
|
82.0 Percentage of participants
Interval 76.0 to 87.0
|
|
Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination
Pain at the injection site: Mild
|
41.7 Percentage of participants
Interval 34.8 to 48.8
|
47.0 Percentage of participants
Interval 40.2 to 53.9
|
56.8 Percentage of participants
Interval 49.6 to 63.8
|
62.9 Percentage of participants
Interval 55.9 to 69.6
|
|
Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0.5 Percentage of participants
Interval 0.0 to 2.6
|
1.0 Percentage of participants
Interval 0.1 to 3.6
|
0 Percentage of participants
Interval 0.0 to 1.8
|
|
Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination
Redness: Any
|
37.7 Percentage of participants
Interval 31.1 to 44.8
|
39.1 Percentage of participants
Interval 32.5 to 45.9
|
37.2 Percentage of participants
Interval 30.5 to 44.3
|
15.1 Percentage of participants
Interval 10.5 to 20.8
|
|
Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination
Redness: Mild
|
30.4 Percentage of participants
Interval 24.2 to 37.2
|
22.8 Percentage of participants
Interval 17.4 to 29.0
|
16.6 Percentage of participants
Interval 11.7 to 22.5
|
10.7 Percentage of participants
Interval 6.8 to 15.8
|
|
Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination
Redness: Moderate
|
7.4 Percentage of participants
Interval 4.2 to 11.8
|
15.3 Percentage of participants
Interval 10.8 to 20.9
|
18.6 Percentage of participants
Interval 13.4 to 24.7
|
3.9 Percentage of participants
Interval 1.7 to 7.5
|
|
Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0.9 Percentage of participants
Interval 0.1 to 3.3
|
2.0 Percentage of participants
Interval 0.6 to 5.1
|
0.5 Percentage of participants
Interval 0.0 to 2.7
|
|
Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination
Swelling: Any
|
22.1 Percentage of participants
Interval 16.6 to 28.4
|
23.3 Percentage of participants
Interval 17.8 to 29.5
|
27.1 Percentage of participants
Interval 21.1 to 33.9
|
15.6 Percentage of participants
Interval 10.9 to 21.3
|
|
Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination
Swelling: Mild
|
15.7 Percentage of participants
Interval 11.0 to 21.4
|
11.6 Percentage of participants
Interval 7.7 to 16.7
|
10.6 Percentage of participants
Interval 6.7 to 15.7
|
5.4 Percentage of participants
Interval 2.7 to 9.4
|
|
Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination
Swelling: Moderate
|
6.4 Percentage of participants
Interval 3.4 to 10.7
|
11.2 Percentage of participants
Interval 7.3 to 16.2
|
15.6 Percentage of participants
Interval 10.8 to 21.4
|
10.2 Percentage of participants
Interval 6.5 to 15.2
|
|
Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination
Pain at the injection site: Moderate
|
9.8 Percentage of participants
Interval 6.1 to 14.7
|
17.7 Percentage of participants
Interval 12.8 to 23.4
|
24.6 Percentage of participants
Interval 18.8 to 31.2
|
17.6 Percentage of participants
Interval 12.6 to 23.5
|
|
Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination
Pain at the injection site: Severe
|
1.0 Percentage of participants
Interval 0.1 to 3.5
|
1.4 Percentage of participants
Interval 0.3 to 4.0
|
1.5 Percentage of participants
Interval 0.3 to 4.3
|
1.5 Percentage of participants
Interval 0.3 to 4.2
|
PRIMARY outcome
Timeframe: Within 7 days after vaccination on Day 1Population: Safety population included all participants who received 20vPnC and had safety follow-up after vaccination. Here, "Number of Participants Analyzed" signifies the number of participants with any electronic diary data after vaccination.
Systemic events for Cohort 1 included fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. Fever was defined as temperature \>=38.0 degrees Celsius (C) and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0-degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
Cohort 1: 20vPnC: >=15 to <24 Months
n=204 Participants
Participants aged greater than \>=15 months to \<24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 2: 20vPnC: >=2 to <5 Years
Participants aged \>=2 to \<5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 3: 20vPnC: >=5 to <10 Years
Participants aged \>=5 to \<10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
Cohort 4: 20vPnC: >=10 to <18 Years
Participants aged \>=10 to \<18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1
Fever: >=38.0 degrees C
|
11.8 Percentage of participants
Interval 7.7 to 17.0
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1
Fever: >=38.0 degrees C to 38.4 degrees C
|
5.9 Percentage of participants
Interval 3.1 to 10.0
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1
Fever: >38.4 degrees C to 38.9 degrees C
|
2.9 Percentage of participants
Interval 1.1 to 6.3
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1
Fever: >38.9 degrees C to 40.0 degrees C
|
2.9 Percentage of participants
Interval 1.1 to 6.3
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1
Fever: >40.0 degrees C
|
0 Percentage of participants
Interval 0.0 to 1.8
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1
Decreased appetite: Any
|
25.0 Percentage of participants
Interval 19.2 to 31.5
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1
Decreased appetite: Mild
|
17.6 Percentage of participants
Interval 12.7 to 23.6
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1
Decreased appetite: Moderate
|
6.4 Percentage of participants
Interval 3.4 to 10.7
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1
Decreased appetite: Severe
|
1.0 Percentage of participants
Interval 0.1 to 3.5
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1
Drowsiness/increased sleep: Any
|
41.7 Percentage of participants
Interval 34.8 to 48.8
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1
Drowsiness/increased sleep: Mild
|
31.4 Percentage of participants
Interval 25.1 to 38.2
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1
Drowsiness/increased sleep: Moderate
|
9.3 Percentage of participants
Interval 5.7 to 14.2
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1
Drowsiness/increased sleep: Severe
|
1.0 Percentage of participants
Interval 0.1 to 3.5
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1
Irritability: Any
|
61.8 Percentage of participants
Interval 54.7 to 68.5
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1
Irritability: Mild
|
22.5 Percentage of participants
Interval 17.0 to 28.9
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1
Irritability: Moderate
|
37.3 Percentage of participants
Interval 30.6 to 44.3
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1
Irritability: Severe
|
2.0 Percentage of participants
Interval 0.5 to 4.9
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days after vaccination on Day 1Population: Safety population included all participants who received 20vPnC and had safety follow-up after vaccination. Here, "Number of Participants Analyzed" signifies the number of participants with any electronic diary data after vaccination.
Systemic events for Cohort 2-4 included fever, fatigue, headache, muscle pain and joint pain, recorded by parents/legal guardians of participant's using an e-diary. Fever was defined as temperature \>=38.0 degrees C and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevents daily routine activity). 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
Cohort 1: 20vPnC: >=15 to <24 Months
n=215 Participants
Participants aged greater than \>=15 months to \<24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 2: 20vPnC: >=2 to <5 Years
n=199 Participants
Participants aged \>=2 to \<5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 3: 20vPnC: >=5 to <10 Years
n=205 Participants
Participants aged \>=5 to \<10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
Cohort 4: 20vPnC: >=10 to <18 Years
Participants aged \>=10 to \<18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
Fever: >38.4 degrees C to 38.9 degrees C
|
1.4 Percentage of participants
Interval 0.3 to 4.0
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.8
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
Fever: >38.9 degrees C to 40.0 degrees C
|
0.5 Percentage of participants
Interval 0.0 to 2.6
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.8
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
Muscle pain: Moderate
|
8.4 Percentage of participants
Interval 5.0 to 12.9
|
11.1 Percentage of participants
Interval 7.1 to 16.3
|
13.2 Percentage of participants
Interval 8.9 to 18.6
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
Fever: >=38.0 degrees C
|
3.3 Percentage of participants
Interval 1.3 to 6.6
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
0 Percentage of participants
Interval 0.0 to 1.8
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
Fever: >=38.0 degrees C to 38.4 degrees C
|
1.4 Percentage of participants
Interval 0.3 to 4.0
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
0 Percentage of participants
Interval 0.0 to 1.8
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
Fever: >40.0 degrees C
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.8
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
Fatigue: Any
|
37.2 Percentage of participants
Interval 30.7 to 44.0
|
28.1 Percentage of participants
Interval 22.0 to 34.9
|
27.8 Percentage of participants
Interval 21.8 to 34.5
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
Fatigue: Mild
|
21.9 Percentage of participants
Interval 16.5 to 28.0
|
19.1 Percentage of participants
Interval 13.9 to 25.3
|
15.6 Percentage of participants
Interval 10.9 to 21.3
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
Fatigue: Moderate
|
14.4 Percentage of participants
Interval 10.0 to 19.8
|
8.5 Percentage of participants
Interval 5.1 to 13.3
|
12.2 Percentage of participants
Interval 8.0 to 17.5
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
Fatigue: Severe
|
0.9 Percentage of participants
Interval 0.1 to 3.3
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
0 Percentage of participants
Interval 0.0 to 1.8
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
Headache: Any
|
5.6 Percentage of participants
Interval 2.9 to 9.5
|
18.6 Percentage of participants
Interval 13.4 to 24.7
|
29.3 Percentage of participants
Interval 23.1 to 36.0
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
Headache: Mild
|
3.3 Percentage of participants
Interval 1.3 to 6.6
|
14.6 Percentage of participants
Interval 10.0 to 20.3
|
20.0 Percentage of participants
Interval 14.8 to 26.1
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
Headache: Moderate
|
1.9 Percentage of participants
Interval 0.5 to 4.7
|
3.0 Percentage of participants
Interval 1.1 to 6.4
|
7.8 Percentage of participants
Interval 4.5 to 12.4
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
Headache: Severe
|
0.5 Percentage of participants
Interval 0.0 to 2.6
|
1.0 Percentage of participants
Interval 0.1 to 3.6
|
1.5 Percentage of participants
Interval 0.3 to 4.2
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
Muscle pain: Any
|
26.5 Percentage of participants
Interval 20.7 to 32.9
|
39.2 Percentage of participants
Interval 32.4 to 46.3
|
48.3 Percentage of participants
Interval 41.3 to 55.4
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
Muscle pain: Mild
|
17.7 Percentage of participants
Interval 12.8 to 23.4
|
26.6 Percentage of participants
Interval 20.6 to 33.3
|
34.6 Percentage of participants
Interval 28.1 to 41.6
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
Muscle pain: Severe
|
0.5 Percentage of participants
Interval 0.0 to 2.6
|
1.5 Percentage of participants
Interval 0.3 to 4.3
|
0.5 Percentage of participants
Interval 0.0 to 2.7
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
Joint pain: Any
|
3.7 Percentage of participants
Interval 1.6 to 7.2
|
6.5 Percentage of participants
Interval 3.5 to 10.9
|
8.3 Percentage of participants
Interval 4.9 to 12.9
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
Joint pain: Mild
|
2.3 Percentage of participants
Interval 0.8 to 5.3
|
3.0 Percentage of participants
Interval 1.1 to 6.4
|
3.4 Percentage of participants
Interval 1.4 to 6.9
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
Joint pain: Moderate
|
1.4 Percentage of participants
Interval 0.3 to 4.0
|
3.0 Percentage of participants
Interval 1.1 to 6.4
|
4.9 Percentage of participants
Interval 2.4 to 8.8
|
—
|
|
Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4
Joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
0 Percentage of participants
Interval 0.0 to 1.8
|
—
|
PRIMARY outcome
Timeframe: From vaccination (on Day 1) up to 1 month after vaccinationPopulation: Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
Cohort 1: 20vPnC: >=15 to <24 Months
n=209 Participants
Participants aged greater than \>=15 months to \<24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 2: 20vPnC: >=2 to <5 Years
n=216 Participants
Participants aged \>=2 to \<5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 3: 20vPnC: >=5 to <10 Years
n=201 Participants
Participants aged \>=5 to \<10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
Cohort 4: 20vPnC: >=10 to <18 Years
n=205 Participants
Participants aged \>=10 to \<18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Adverse Events (AEs) up to 1 Month After Vaccination
|
23.9 Percentage of participants
95% Confidence Interval 18.3 • Interval 18.3 to 30.3
|
7.9 Percentage of participants
95% Confidence Interval 4.7 • Interval 4.7 to 12.3
|
6.5 Percentage of participants
95% Confidence Interval 3.5 • Interval 3.5 to 10.8
|
4.4 Percentage of participants
95% Confidence Interval 2.0 • Interval 2.0 to 8.2
|
PRIMARY outcome
Timeframe: From vaccination (on Day 1) up to 6 months after vaccinationPopulation: Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
An SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
Cohort 1: 20vPnC: >=15 to <24 Months
n=209 Participants
Participants aged greater than \>=15 months to \<24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 2: 20vPnC: >=2 to <5 Years
n=216 Participants
Participants aged \>=2 to \<5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 3: 20vPnC: >=5 to <10 Years
n=201 Participants
Participants aged \>=5 to \<10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
Cohort 4: 20vPnC: >=10 to <18 Years
n=205 Participants
Participants aged \>=10 to \<18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Serious Adverse Events (SAEs) up to 6 Months After Vaccination
|
1.0 Percentage of participants
Interval 0.1 to 3.4
|
0 Percentage of participants
Interval 0.0 to 1.7
|
0 Percentage of participants
Interval 0.0 to 1.8
|
1.5 Percentage of participants
Interval 0.3 to 4.2
|
PRIMARY outcome
Timeframe: From vaccination (on Day 1) up to 6 months after vaccinationPopulation: Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
Cohort 1: 20vPnC: >=15 to <24 Months
n=209 Participants
Participants aged greater than \>=15 months to \<24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 2: 20vPnC: >=2 to <5 Years
n=216 Participants
Participants aged \>=2 to \<5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 3: 20vPnC: >=5 to <10 Years
n=201 Participants
Participants aged \>=5 to \<10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
Cohort 4: 20vPnC: >=10 to <18 Years
n=205 Participants
Participants aged \>=10 to \<18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 Months After Vaccination
|
3.3 Percentage of participants
Interval 1.4 to 6.8
|
0.5 Percentage of participants
Interval 0.0 to 2.6
|
0.5 Percentage of participants
Interval 0.0 to 2.7
|
1.0 Percentage of participants
Interval 0.1 to 3.5
|
PRIMARY outcome
Timeframe: Before vaccination on Day 1 to 1 month after vaccinationPopulation: Evaluable immunogenicity population (EIP) included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days after vaccination for Cohorts 1-2; no other major protocol deviations. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants with valid assay results at both timepoints for the specified serotype.
Pneumococcal serotype-specific IgG concentrations were measured from serum samples for the 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding 2-sided 95% CIs (based on Student's t distribution). Superiority of IgG concentration 1 month after 20vPnC to before vaccination for each serotype was demonstrated if the 95% lower CI of GMFR was \>1.
Outcome measures
| Measure |
Cohort 1: 20vPnC: >=15 to <24 Months
n=188 Participants
Participants aged greater than \>=15 months to \<24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 2: 20vPnC: >=2 to <5 Years
n=182 Participants
Participants aged \>=2 to \<5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 3: 20vPnC: >=5 to <10 Years
Participants aged \>=5 to \<10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
Cohort 4: 20vPnC: >=10 to <18 Years
Participants aged \>=10 to \<18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2
Serotype 8
|
113.4 Fold rise
Interval 93.2 to 137.9
|
107.0 Fold rise
Interval 86.1 to 133.0
|
—
|
—
|
|
Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2
Serotype 10A
|
83.2 Fold rise
Interval 69.1 to 100.2
|
106.7 Fold rise
Interval 86.2 to 132.0
|
—
|
—
|
|
Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2
Serotype 11A
|
62.7 Fold rise
Interval 49.9 to 78.8
|
43.6 Fold rise
Interval 33.2 to 57.1
|
—
|
—
|
|
Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2
Serotype 12F
|
27.9 Fold rise
Interval 22.9 to 34.1
|
36.6 Fold rise
Interval 30.1 to 44.7
|
—
|
—
|
|
Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2
Serotype 15B
|
52.1 Fold rise
Interval 43.2 to 62.8
|
73.3 Fold rise
Interval 58.7 to 91.5
|
—
|
—
|
|
Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2
Serotype 22F
|
1847.7 Fold rise
Interval 1481.3 to 2304.5
|
796.2 Fold rise
Interval 577.1 to 1098.4
|
—
|
—
|
|
Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2
Serotype 33F
|
113.5 Fold rise
Interval 92.5 to 139.2
|
78.3 Fold rise
Interval 61.6 to 99.5
|
—
|
—
|
PRIMARY outcome
Timeframe: Before vaccination on Day 1 to 1 month after vaccinationPopulation: EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 49 days after vaccination for Cohorts 3-4; no other major protocol deviations. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants with valid assay results at both timepoints for the specified serotype.
Pneumococcal serotype-specific OPA titers were measured from serum samples for 7 the additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution). Superiority of OPA titers 1 month after 20vPnC to before vaccination for each serotype was demonstrated if the 95% lower CI of the GMFR was \>1.
Outcome measures
| Measure |
Cohort 1: 20vPnC: >=15 to <24 Months
n=154 Participants
Participants aged greater than \>=15 months to \<24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 2: 20vPnC: >=2 to <5 Years
n=174 Participants
Participants aged \>=2 to \<5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 3: 20vPnC: >=5 to <10 Years
Participants aged \>=5 to \<10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
Cohort 4: 20vPnC: >=10 to <18 Years
Participants aged \>=10 to \<18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
|---|---|---|---|---|
|
GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4
Serotype 8
|
106.5 Fold rise
Interval 79.9 to 142.0
|
86.3 Fold rise
Interval 64.2 to 115.9
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4
Serotype 10A
|
30.6 Fold rise
Interval 20.1 to 46.6
|
33.5 Fold rise
Interval 22.3 to 50.1
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4
Serotype 11A
|
11.6 Fold rise
Interval 7.6 to 17.7
|
14.9 Fold rise
Interval 10.2 to 21.8
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4
Serotype 12F
|
463.6 Fold rise
Interval 332.3 to 646.7
|
454.1 Fold rise
Interval 333.3 to 618.7
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4
Serotype 15B
|
380.8 Fold rise
Interval 228.3 to 635.2
|
499.0 Fold rise
Interval 338.7 to 735.3
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4
Serotype 22F
|
128.5 Fold rise
Interval 76.7 to 215.3
|
111.2 Fold rise
Interval 67.1 to 184.3
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4
Serotype 33F
|
14.2 Fold rise
Interval 10.9 to 18.4
|
11.5 Fold rise
Interval 8.9 to 14.9
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1 Month after vaccination on Day 1Population: EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days after vaccination for Cohort 1; no other major protocol deviations.
Pneumococcal serotype-specific IgG concentrations were measured from serum samples for the 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. Percentage of participants with predefined level (\>=0.35 micrograms per milliliter) of IgG concentration for the 7 additional 20vPnC serotypes was presented. 2-sided 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
Cohort 1: 20vPnC: >=15 to <24 Months
n=190 Participants
Participants aged greater than \>=15 months to \<24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 2: 20vPnC: >=2 to <5 Years
Participants aged \>=2 to \<5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 3: 20vPnC: >=5 to <10 Years
Participants aged \>=5 to \<10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
Cohort 4: 20vPnC: >=10 to <18 Years
Participants aged \>=10 to \<18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Predefined Levels of Pneumococcal Serotype-Specific IgG Concentrations for the 7 Additional Serotypes at 1 Month After Vaccination in Cohort 1 Only
Serotype 8
|
100.0 Percentage of participants
95% Confidence Interval 98.1 • Interval 98.1 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants With Predefined Levels of Pneumococcal Serotype-Specific IgG Concentrations for the 7 Additional Serotypes at 1 Month After Vaccination in Cohort 1 Only
Serotype 10A
|
83.2 Percentage of participants
95% Confidence Interval 77.1 • Interval 77.1 to 88.2
|
—
|
—
|
—
|
|
Percentage of Participants With Predefined Levels of Pneumococcal Serotype-Specific IgG Concentrations for the 7 Additional Serotypes at 1 Month After Vaccination in Cohort 1 Only
Serotype 11A
|
93.2 Percentage of participants
95% Confidence Interval 88.6 • Interval 88.6 to 96.3
|
—
|
—
|
—
|
|
Percentage of Participants With Predefined Levels of Pneumococcal Serotype-Specific IgG Concentrations for the 7 Additional Serotypes at 1 Month After Vaccination in Cohort 1 Only
Serotype 12F
|
40.0 Percentage of participants
95% Confidence Interval 33.0 • Interval 33.0 to 47.3
|
—
|
—
|
—
|
|
Percentage of Participants With Predefined Levels of Pneumococcal Serotype-Specific IgG Concentrations for the 7 Additional Serotypes at 1 Month After Vaccination in Cohort 1 Only
Serotype 15B
|
83.7 Percentage of participants
95% Confidence Interval 77.6 • Interval 77.6 to 88.6
|
—
|
—
|
—
|
|
Percentage of Participants With Predefined Levels of Pneumococcal Serotype-Specific IgG Concentrations for the 7 Additional Serotypes at 1 Month After Vaccination in Cohort 1 Only
Serotype 22F
|
98.9 Percentage of participants
95% Confidence Interval 96.2 • Interval 96.2 to 99.9
|
—
|
—
|
—
|
|
Percentage of Participants With Predefined Levels of Pneumococcal Serotype-Specific IgG Concentrations for the 7 Additional Serotypes at 1 Month After Vaccination in Cohort 1 Only
Serotype 33F
|
92.6 Percentage of participants
95% Confidence Interval 87.9 • Interval 87.9 to 95.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before vaccination on Day 1 to 1 month after vaccinationPopulation: EIP included all participants who were eligible; received 20vPnC;at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days or 27 to 49 days after vaccination for Cohort 2 or Cohorts 3-4, respectively; no other major protocol deviations. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants with valid assay results at both timepoints for the specified serotype.
Pneumococcal serotype-specific OPA titers were measured from serum samples for 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. Percentage of participants with \>=4-fold rise in serotype-specific OPA titers from before vaccination to 1 month after vaccination with 20vPnC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. OPA titers were measured in a randomized subset of samples in Cohort 2 for this outcome measure.
Outcome measures
| Measure |
Cohort 1: 20vPnC: >=15 to <24 Months
n=76 Participants
Participants aged greater than \>=15 months to \<24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 2: 20vPnC: >=2 to <5 Years
n=154 Participants
Participants aged \>=2 to \<5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 3: 20vPnC: >=5 to <10 Years
n=174 Participants
Participants aged \>=5 to \<10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
Cohort 4: 20vPnC: >=10 to <18 Years
Participants aged \>=10 to \<18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only
Serotype 8
|
93.2 Percentage of participants
Interval 84.9 to 97.8
|
92.2 Percentage of participants
Interval 86.7 to 95.9
|
89.1 Percentage of participants
Interval 83.5 to 93.3
|
—
|
|
Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only
Serotype 10A
|
84.9 Percentage of participants
Interval 74.6 to 92.2
|
80.6 Percentage of participants
Interval 72.9 to 86.9
|
81.7 Percentage of participants
Interval 74.3 to 87.7
|
—
|
|
Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only
Serotype 11A
|
86.5 Percentage of participants
Interval 74.2 to 94.4
|
66.2 Percentage of participants
Interval 57.6 to 74.1
|
62.6 Percentage of participants
Interval 54.5 to 70.2
|
—
|
|
Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only
Serotype: 12F
|
94.6 Percentage of participants
Interval 86.7 to 98.5
|
96.8 Percentage of participants
Interval 92.6 to 98.9
|
94.5 Percentage of participants
Interval 89.8 to 97.5
|
—
|
|
Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only
Serotype: 15B
|
88.2 Percentage of participants
Interval 78.7 to 94.4
|
89.4 Percentage of participants
Interval 83.2 to 94.0
|
93.9 Percentage of participants
Interval 89.1 to 97.0
|
—
|
|
Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only
Serotype: 22F
|
86.8 Percentage of participants
Interval 76.4 to 93.8
|
87.6 Percentage of participants
Interval 80.9 to 92.6
|
81.0 Percentage of participants
Interval 74.2 to 86.6
|
—
|
|
Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only
Serotype: 33F
|
71.2 Percentage of participants
Interval 59.4 to 81.2
|
79.9 Percentage of participants
Interval 72.4 to 86.1
|
75.3 Percentage of participants
Interval 67.8 to 81.8
|
—
|
SECONDARY outcome
Timeframe: Before vaccination and 1 month after vaccinationPopulation: EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days or within 27 to 49 days after vaccination for Cohorts 1-2 or Cohorts 3-4, respectively; no other major protocol deviations. Here, "Number of Participants Analyzed" signifies participants included in the EIP and "Number Analyzed" signifies participants with valid IgG concentrations at the specified timepoint for specified serotype.
Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMCs the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding 2-sided 95% CIs (based on the Student's t distribution).
Outcome measures
| Measure |
Cohort 1: 20vPnC: >=15 to <24 Months
n=190 Participants
Participants aged greater than \>=15 months to \<24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 2: 20vPnC: >=2 to <5 Years
n=183 Participants
Participants aged \>=2 to \<5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 3: 20vPnC: >=5 to <10 Years
n=186 Participants
Participants aged \>=5 to \<10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
Cohort 4: 20vPnC: >=10 to <18 Years
n=198 Participants
Participants aged \>=10 to \<18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 6B
|
0.85 Micrograms per milliliter
Interval 0.71 to 1.02
|
0.52 Micrograms per milliliter
Interval 0.42 to 0.63
|
0.26 Micrograms per milliliter
Interval 0.2 to 0.32
|
0.40 Micrograms per milliliter
Interval 0.31 to 0.51
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 11A
|
0.03 Micrograms per milliliter
Interval 0.02 to 0.03
|
0.06 Micrograms per milliliter
Interval 0.04 to 0.08
|
0.12 Micrograms per milliliter
Interval 0.09 to 0.16
|
0.30 Micrograms per milliliter
Interval 0.23 to 0.38
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 18C
|
2.69 Micrograms per milliliter
Interval 2.32 to 3.12
|
7.07 Micrograms per milliliter
Interval 6.01 to 8.32
|
10.83 Micrograms per milliliter
Interval 9.53 to 12.3
|
8.61 Micrograms per milliliter
Interval 7.34 to 10.1
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 18C
|
0.65 Micrograms per milliliter
Interval 0.55 to 0.76
|
0.26 Micrograms per milliliter
Interval 0.21 to 0.32
|
0.12 Micrograms per milliliter
Interval 0.09 to 0.14
|
0.13 Micrograms per milliliter
Interval 0.11 to 0.17
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 1
|
0.43 Micrograms per milliliter
Interval 0.37 to 0.49
|
0.20 Micrograms per milliliter
Interval 0.17 to 0.24
|
0.12 Micrograms per milliliter
Interval 0.1 to 0.14
|
0.09 Micrograms per milliliter
Interval 0.08 to 0.11
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 1
|
1.46 Micrograms per milliliter
Interval 1.28 to 1.67
|
4.21 Micrograms per milliliter
Interval 3.62 to 4.9
|
5.86 Micrograms per milliliter
Interval 5.15 to 6.67
|
4.04 Micrograms per milliliter
Interval 3.32 to 4.93
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 3
|
0.14 Micrograms per milliliter
Interval 0.12 to 0.16
|
0.08 Micrograms per milliliter
Interval 0.06 to 0.1
|
0.22 Micrograms per milliliter
Interval 0.17 to 0.3
|
0.15 Micrograms per milliliter
Interval 0.11 to 0.2
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 3
|
0.54 Micrograms per milliliter
Interval 0.47 to 0.61
|
1.21 Micrograms per milliliter
Interval 1.04 to 1.42
|
1.32 Micrograms per milliliter
Interval 1.16 to 1.5
|
0.62 Micrograms per milliliter
Interval 0.52 to 0.76
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 4
|
0.61 Micrograms per milliliter
Interval 0.52 to 0.72
|
0.30 Micrograms per milliliter
Interval 0.25 to 0.37
|
0.13 Micrograms per milliliter
Interval 0.11 to 0.16
|
0.12 Micrograms per milliliter
Interval 0.1 to 0.15
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 4
|
2.59 Micrograms per milliliter
Interval 2.27 to 2.96
|
8.37 Micrograms per milliliter
Interval 7.28 to 9.62
|
9.76 Micrograms per milliliter
Interval 8.54 to 11.15
|
6.37 Micrograms per milliliter
Interval 5.39 to 7.53
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 5
|
0.43 Micrograms per milliliter
Interval 0.36 to 0.5
|
0.18 Micrograms per milliliter
Interval 0.15 to 0.22
|
0.07 Micrograms per milliliter
Interval 0.06 to 0.08
|
0.04 Micrograms per milliliter
Interval 0.03 to 0.06
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 5
|
1.53 Micrograms per milliliter
Interval 1.32 to 1.77
|
5.09 Micrograms per milliliter
Interval 4.32 to 5.99
|
7.50 Micrograms per milliliter
Interval 6.52 to 8.63
|
2.58 Micrograms per milliliter
Interval 1.88 to 3.53
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 6A
|
1.61 Micrograms per milliliter
Interval 1.38 to 1.88
|
0.71 Micrograms per milliliter
Interval 0.58 to 0.88
|
0.50 Micrograms per milliliter
Interval 0.39 to 0.65
|
0.28 Micrograms per milliliter
Interval 0.22 to 0.37
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 6A
|
7.59 Micrograms per milliliter
Interval 6.67 to 8.63
|
31.99 Micrograms per milliliter
Interval 27.85 to 36.75
|
46.28 Micrograms per milliliter
Interval 39.9 to 53.67
|
20.03 Micrograms per milliliter
Interval 15.39 to 26.07
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 6B
|
4.27 Micrograms per milliliter
Interval 3.69 to 4.94
|
17.78 Micrograms per milliliter
Interval 15.43 to 20.48
|
32.45 Micrograms per milliliter
Interval 27.9 to 37.74
|
38.82 Micrograms per milliliter
Interval 31.49 to 47.86
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 7F
|
1.17 Micrograms per milliliter
Interval 1.03 to 1.33
|
0.51 Micrograms per milliliter
Interval 0.44 to 0.6
|
0.18 Micrograms per milliliter
Interval 0.16 to 0.21
|
0.11 Micrograms per milliliter
Interval 0.08 to 0.14
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 7F
|
3.53 Micrograms per milliliter
Interval 3.16 to 3.94
|
6.42 Micrograms per milliliter
Interval 5.69 to 7.24
|
7.92 Micrograms per milliliter
Interval 7.03 to 8.93
|
3.19 Micrograms per milliliter
Interval 2.65 to 3.85
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 9V
|
0.71 Micrograms per milliliter
Interval 0.61 to 0.83
|
0.35 Micrograms per milliliter
Interval 0.28 to 0.42
|
0.14 Micrograms per milliliter
Interval 0.11 to 0.17
|
0.14 Micrograms per milliliter
Interval 0.11 to 0.18
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 9V
|
2.70 Micrograms per milliliter
Interval 2.35 to 3.09
|
7.94 Micrograms per milliliter
Interval 6.83 to 9.24
|
10.86 Micrograms per milliliter
Interval 9.41 to 12.54
|
7.67 Micrograms per milliliter
Interval 6.52 to 9.02
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 14
|
1.53 Micrograms per milliliter
Interval 1.31 to 1.79
|
0.66 Micrograms per milliliter
Interval 0.53 to 0.81
|
0.42 Micrograms per milliliter
Interval 0.33 to 0.53
|
0.29 Micrograms per milliliter
Interval 0.23 to 0.37
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 14
|
4.42 Micrograms per milliliter
Interval 3.82 to 5.12
|
14.60 Micrograms per milliliter
Interval 12.44 to 17.13
|
28.54 Micrograms per milliliter
Interval 24.77 to 32.89
|
28.17 Micrograms per milliliter
Interval 23.9 to 33.21
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 19A
|
0.47 Micrograms per milliliter
Interval 0.38 to 0.58
|
0.52 Micrograms per milliliter
Interval 0.4 to 0.68
|
0.78 Micrograms per milliliter
Interval 0.58 to 1.04
|
0.55 Micrograms per milliliter
Interval 0.43 to 0.7
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 19A
|
3.29 Micrograms per milliliter
Interval 2.89 to 3.76
|
12.48 Micrograms per milliliter
Interval 10.76 to 14.48
|
13.65 Micrograms per milliliter
Interval 11.96 to 15.59
|
8.89 Micrograms per milliliter
Interval 7.29 to 10.84
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 19F
|
0.80 Micrograms per milliliter
Interval 0.67 to 0.94
|
0.56 Micrograms per milliliter
Interval 0.44 to 0.71
|
0.96 Micrograms per milliliter
Interval 0.7 to 1.32
|
0.82 Micrograms per milliliter
Interval 0.63 to 1.06
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 19F
|
4.16 Micrograms per milliliter
Interval 3.61 to 4.79
|
12.50 Micrograms per milliliter
Interval 10.48 to 14.91
|
14.62 Micrograms per milliliter
Interval 12.32 to 17.36
|
6.55 Micrograms per milliliter
Interval 5.6 to 7.66
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 23F
|
0.96 Micrograms per milliliter
Interval 0.79 to 1.18
|
0.90 Micrograms per milliliter
Interval 0.71 to 1.15
|
0.82 Micrograms per milliliter
Interval 0.64 to 1.06
|
0.61 Micrograms per milliliter
Interval 0.48 to 0.78
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 23F
|
5.35 Micrograms per milliliter
Interval 4.55 to 6.3
|
16.18 Micrograms per milliliter
Interval 13.75 to 19.04
|
22.69 Micrograms per milliliter
Interval 19.4 to 26.53
|
19.16 Micrograms per milliliter
Interval 16.31 to 22.51
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 8
|
0.04 Micrograms per milliliter
Interval 0.03 to 0.05
|
0.05 Micrograms per milliliter
Interval 0.04 to 0.06
|
0.08 Micrograms per milliliter
Interval 0.07 to 0.1
|
0.16 Micrograms per milliliter
Interval 0.12 to 0.2
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 8
|
4.66 Micrograms per milliliter
Interval 4.17 to 5.22
|
5.08 Micrograms per milliliter
Interval 4.45 to 5.8
|
4.65 Micrograms per milliliter
Interval 4.05 to 5.34
|
4.26 Micrograms per milliliter
Interval 3.67 to 4.94
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 10A
|
0.01 Micrograms per milliliter
Interval 0.01 to 0.02
|
0.03 Micrograms per milliliter
Interval 0.02 to 0.03
|
0.07 Micrograms per milliliter
Interval 0.06 to 0.09
|
0.15 Micrograms per milliliter
Interval 0.12 to 0.19
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 10A
|
1.23 Micrograms per milliliter
Interval 1.02 to 1.48
|
2.76 Micrograms per milliliter
Interval 2.28 to 3.34
|
3.98 Micrograms per milliliter
Interval 3.25 to 4.88
|
5.35 Micrograms per milliliter
Interval 4.2 to 6.81
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 11A
|
1.61 Micrograms per milliliter
Interval 1.4 to 1.86
|
2.64 Micrograms per milliliter
Interval 2.25 to 3.09
|
2.80 Micrograms per milliliter
Interval 2.35 to 3.33
|
3.13 Micrograms per milliliter
Interval 2.6 to 3.77
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 12F
|
0.01 Micrograms per milliliter
Interval 0.01 to 0.01
|
0.01 Micrograms per milliliter
Interval 0.01 to 0.01
|
0.01 Micrograms per milliliter
Interval 0.01 to 0.01
|
0.01 Micrograms per milliliter
Interval 0.01 to 0.01
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 12F
|
0.22 Micrograms per milliliter
Interval 0.18 to 0.27
|
0.38 Micrograms per milliliter
Interval 0.31 to 0.46
|
0.36 Micrograms per milliliter
Interval 0.29 to 0.44
|
0.28 Micrograms per milliliter
Interval 0.22 to 0.34
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 15B
|
0.02 Micrograms per milliliter
Interval 0.02 to 0.03
|
0.05 Micrograms per milliliter
Interval 0.04 to 0.07
|
0.20 Micrograms per milliliter
Interval 0.15 to 0.27
|
0.35 Micrograms per milliliter
Interval 0.27 to 0.45
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 15B
|
1.17 Micrograms per milliliter
Interval 0.97 to 1.4
|
3.96 Micrograms per milliliter
Interval 3.12 to 5.03
|
10.74 Micrograms per milliliter
Interval 8.49 to 13.6
|
18.79 Micrograms per milliliter
Interval 15.16 to 23.28
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 22F
|
0.01 Micrograms per milliliter
Interval 0.0 to 0.01
|
0.02 Micrograms per milliliter
Interval 0.01 to 0.02
|
0.08 Micrograms per milliliter
Interval 0.06 to 0.11
|
0.14 Micrograms per milliliter
Interval 0.11 to 0.19
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 22F
|
9.57 Micrograms per milliliter
Interval 8.12 to 11.29
|
12.46 Micrograms per milliliter
Interval 10.82 to 14.35
|
15.68 Micrograms per milliliter
Interval 13.45 to 18.29
|
12.36 Micrograms per milliliter
Interval 10.38 to 14.72
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 33F
|
0.02 Micrograms per milliliter
Interval 0.01 to 0.02
|
0.04 Micrograms per milliliter
Interval 0.03 to 0.05
|
0.10 Micrograms per milliliter
Interval 0.08 to 0.12
|
0.18 Micrograms per milliliter
Interval 0.14 to 0.22
|
|
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 33F
|
1.91 Micrograms per milliliter
Interval 1.6 to 2.27
|
3.16 Micrograms per milliliter
Interval 2.63 to 3.79
|
3.87 Micrograms per milliliter
Interval 3.24 to 4.61
|
3.93 Micrograms per milliliter
Interval 3.25 to 4.75
|
SECONDARY outcome
Timeframe: Before vaccination on Day 1 to 1 month after vaccinationPopulation: EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days after vaccination for Cohorts 1-2; no other major protocol deviations. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants with valid assay results at both timepoints for the specified serotype.
Pneumococcal serotype-specific IgG concentrations were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution).
Outcome measures
| Measure |
Cohort 1: 20vPnC: >=15 to <24 Months
n=189 Participants
Participants aged greater than \>=15 months to \<24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 2: 20vPnC: >=2 to <5 Years
n=183 Participants
Participants aged \>=2 to \<5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 3: 20vPnC: >=5 to <10 Years
Participants aged \>=5 to \<10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
Cohort 4: 20vPnC: >=10 to <18 Years
Participants aged \>=10 to \<18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
|---|---|---|---|---|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2
Serotype 19A
|
6.9 Fold rise
Interval 5.7 to 8.4
|
24.1 Fold rise
Interval 19.0 to 30.6
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2
Serotype 1
|
3.4 Fold rise
Interval 3.0 to 3.9
|
20.6 Fold rise
Interval 17.2 to 24.7
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2
Serotype 3
|
3.9 Fold rise
Interval 3.4 to 4.5
|
14.9 Fold rise
Interval 12.4 to 17.9
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2
Serotype 4
|
4.3 Fold rise
Interval 3.7 to 5.0
|
27.6 Fold rise
Interval 22.7 to 33.5
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2
Serotype 5
|
3.6 Fold rise
Interval 3.1 to 4.2
|
28.2 Fold rise
Interval 23.0 to 34.6
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2
Serotype 6A
|
4.8 Fold rise
Interval 4.1 to 5.6
|
44.9 Fold rise
Interval 35.8 to 56.3
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2
Serotype 6B
|
5.0 Fold rise
Interval 4.3 to 5.9
|
34.5 Fold rise
Interval 28.3 to 42.0
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2
Serotype 7F
|
3.0 Fold rise
Interval 2.7 to 3.4
|
12.5 Fold rise
Interval 10.5 to 14.9
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2
Serotype 9V
|
3.8 Fold rise
Interval 3.3 to 4.4
|
23.0 Fold rise
Interval 19.0 to 27.8
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2
Serotype 14
|
2.9 Fold rise
Interval 2.5 to 3.3
|
22.2 Fold rise
Interval 18.0 to 27.4
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2
Serotype 18C
|
4.2 Fold rise
Interval 3.6 to 4.9
|
27.2 Fold rise
Interval 22.5 to 32.9
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2
Serotype 19F
|
5.2 Fold rise
Interval 4.4 to 6.3
|
22.3 Fold rise
Interval 17.2 to 28.8
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2
Serotype 23F
|
5.6 Fold rise
Interval 4.8 to 6.6
|
17.9 Fold rise
Interval 14.6 to 21.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Before vaccination on Day 1 to 1 month after vaccinationPopulation: EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 49 days after vaccination for Cohorts 3-4; no other major protocol deviations. Here, "Number of Participants Analyzed" signifies participants included in the EIP and "Number Analyzed" signifies participants with valid assay results at both timepoints for the specified serotype.
Pneumococcal serotype-specific IgG concentrations were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution).
Outcome measures
| Measure |
Cohort 1: 20vPnC: >=15 to <24 Months
n=186 Participants
Participants aged greater than \>=15 months to \<24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 2: 20vPnC: >=2 to <5 Years
n=198 Participants
Participants aged \>=2 to \<5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 3: 20vPnC: >=5 to <10 Years
Participants aged \>=5 to \<10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
Cohort 4: 20vPnC: >=10 to <18 Years
Participants aged \>=10 to \<18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
|---|---|---|---|---|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4
Serotype 22F
|
187.7 Fold rise
Interval 134.6 to 261.7
|
86.2 Fold rise
Interval 64.9 to 114.4
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4
Serotype 1
|
49.4 Fold rise
Interval 41.6 to 58.6
|
44.2 Fold rise
Interval 37.0 to 52.9
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4
Serotype 3
|
5.9 Fold rise
Interval 4.6 to 7.5
|
4.3 Fold rise
Interval 3.5 to 5.2
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4
Serotype 4
|
74.1 Fold rise
Interval 61.4 to 89.4
|
52.0 Fold rise
Interval 42.3 to 64.0
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4
Serotype 5
|
107.0 Fold rise
Interval 89.4 to 128.2
|
59.3 Fold rise
Interval 47.6 to 73.9
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4
Serotype 6A
|
91.9 Fold rise
Interval 67.7 to 124.9
|
72.5 Fold rise
Interval 54.9 to 95.7
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4
Serotype 6B
|
127.9 Fold rise
Interval 101.0 to 162.0
|
99.5 Fold rise
Interval 77.1 to 128.3
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4
Serotype 7F
|
42.9 Fold rise
Interval 36.1 to 51.1
|
30.0 Fold rise
Interval 24.0 to 37.6
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4
Serotype 9V
|
80.3 Fold rise
Interval 64.3 to 100.3
|
54.2 Fold rise
Interval 42.7 to 68.9
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4
Serotype 14
|
68.4 Fold rise
Interval 53.4 to 87.7
|
96.7 Fold rise
Interval 76.6 to 122.1
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4
Serotype 18C
|
93.7 Fold rise
Interval 76.9 to 114.1
|
64.5 Fold rise
Interval 52.3 to 79.4
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4
Serotype 19A
|
17.6 Fold rise
Interval 13.2 to 23.4
|
16.2 Fold rise
Interval 13.1 to 20.0
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4
Serotype 19F
|
15.2 Fold rise
Interval 10.5 to 22.0
|
8.0 Fold rise
Interval 6.0 to 10.7
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4
Serotype 23F
|
27.6 Fold rise
Interval 21.0 to 36.3
|
31.4 Fold rise
Interval 23.8 to 41.5
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4
Serotype 8
|
55.2 Fold rise
Interval 44.8 to 67.9
|
27.3 Fold rise
Interval 21.9 to 33.9
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4
Serotype 10A
|
54.8 Fold rise
Interval 44.4 to 67.7
|
35.9 Fold rise
Interval 29.3 to 43.9
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4
Serotype 11A
|
23.6 Fold rise
Interval 18.6 to 29.9
|
10.5 Fold rise
Interval 8.5 to 12.9
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4
Serotype 12F
|
31.9 Fold rise
Interval 26.7 to 38.3
|
21.4 Fold rise
Interval 17.6 to 26.0
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4
Serotype 15B
|
52.6 Fold rise
Interval 41.3 to 66.9
|
53.8 Fold rise
Interval 43.1 to 67.1
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4
Serotype 33F
|
39.3 Fold rise
Interval 31.6 to 49.0
|
22.4 Fold rise
Interval 18.2 to 27.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Before vaccination on Day 1 and 1 month after vaccinationPopulation: EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days or 27 to 49 days after vaccination for Cohorts 1-2 or Cohorts 3-4, respectively; no other major protocol deviations. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants with valid OPA titers at the specified timepoint for specified serotype.
Pneumococcal serotype-specific OPA titers were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding 2-sided 95% CIs (based on the Student's t distribution). OPA titers were measured in a randomized subset of serum samples in Cohorts 1 and 2. OPA titers for the 13vPnC serotypes were measured in a randomized subset of serum samples in Cohorts 3 and 4.
Outcome measures
| Measure |
Cohort 1: 20vPnC: >=15 to <24 Months
n=94 Participants
Participants aged greater than \>=15 months to \<24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 2: 20vPnC: >=2 to <5 Years
n=86 Participants
Participants aged \>=2 to \<5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 3: 20vPnC: >=5 to <10 Years
n=175 Participants
Participants aged \>=5 to \<10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
Cohort 4: 20vPnC: >=10 to <18 Years
n=187 Participants
Participants aged \>=10 to \<18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 19F
|
44 Titer
Interval 31.0 to 61.0
|
44 Titer
Interval 31.0 to 61.0
|
91 Titer
Interval 66.0 to 125.0
|
57 Titer
Interval 44.0 to 73.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 23F
|
1936 Titer
Interval 1385.0 to 2707.0
|
2493 Titer
Interval 1757.0 to 3539.0
|
2213 Titer
Interval 1751.0 to 2797.0
|
1842 Titer
Interval 1391.0 to 2439.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 8
|
30 Titer
Interval 24.0 to 39.0
|
39 Titer
Interval 29.0 to 54.0
|
34 Titer
Interval 28.0 to 42.0
|
35 Titer
Interval 28.0 to 43.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 11A
|
13350 Titer
Interval 10540.0 to 16910.0
|
14093 Titer
Interval 9904.0 to 20054.0
|
16882 Titer
Interval 13650.0 to 20880.0
|
11677 Titer
Interval 9751.0 to 13982.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 15B
|
30 Titer
Interval 21.0 to 45.0
|
111 Titer
Interval 63.0 to 197.0
|
79 Titer
Interval 54.0 to 115.0
|
45 Titer
Interval 33.0 to 61.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 15B
|
22951 Titer
Interval 17380.0 to 30307.0
|
27095 Titer
Interval 19557.0 to 37538.0
|
25729 Titer
Interval 19647.0 to 33695.0
|
21496 Titer
Interval 16697.0 to 27672.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype: 22F
|
21 Titer
Interval 13.0 to 33.0
|
104 Titer
Interval 55.0 to 194.0
|
259 Titer
Interval 170.0 to 394.0
|
243 Titer
Interval 161.0 to 366.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 6A
|
1707 Titer
Interval 1144.0 to 2547.0
|
5283 Titer
Interval 3954.0 to 7060.0
|
8268 Titer
Interval 6617.0 to 10331.0
|
9434 Titer
Interval 7616.0 to 11686.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 6B
|
110 Titer
Interval 67.0 to 182.0
|
126 Titer
Interval 72.0 to 219.0
|
156 Titer
Interval 99.0 to 244.0
|
237 Titer
Interval 155.0 to 363.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 6B
|
943 Titer
Interval 611.0 to 1455.0
|
3273 Titer
Interval 2390.0 to 4482.0
|
6569 Titer
Interval 5367.0 to 8040.0
|
10085 Titer
Interval 8263.0 to 12309.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 7F
|
705 Titer
Interval 492.0 to 1010.0
|
996 Titer
Interval 748.0 to 1327.0
|
541 Titer
Interval 410.0 to 713.0
|
516 Titer
Interval 381.0 to 698.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 11A
|
88 Titer
Interval 60.0 to 127.0
|
436 Titer
Interval 237.0 to 800.0
|
1347 Titer
Interval 962.0 to 1887.0
|
765 Titer
Interval 543.0 to 1076.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 7F
|
2635 Titer
Interval 2105.0 to 3297.0
|
3409 Titer
Interval 2552.0 to 4556.0
|
3981 Titer
Interval 3446.0 to 4598.0
|
3326 Titer
Interval 2878.0 to 3843.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 9V
|
649 Titer
Interval 350.0 to 1204.0
|
323 Titer
Interval 202.0 to 515.0
|
410 Titer
Interval 289.0 to 580.0
|
469 Titer
Interval 330.0 to 667.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 9V
|
7686 Titer
Interval 5718.0 to 10332.0
|
7210 Titer
Interval 4781.0 to 10876.0
|
11717 Titer
Interval 9262.0 to 14823.0
|
9627 Titer
Interval 7492.0 to 12369.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 14
|
242 Titer
Interval 151.0 to 387.0
|
300 Titer
Interval 186.0 to 484.0
|
246 Titer
Interval 172.0 to 353.0
|
97 Titer
Interval 65.0 to 145.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 14
|
1018 Titer
Interval 748.0 to 1385.0
|
2506 Titer
Interval 1932.0 to 3249.0
|
4610 Titer
Interval 3688.0 to 5762.0
|
3925 Titer
Interval 3153.0 to 4885.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 18C
|
300 Titer
Interval 147.0 to 613.0
|
139 Titer
Interval 69.0 to 277.0
|
152 Titer
Interval 89.0 to 261.0
|
73 Titer
Interval 45.0 to 119.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 18C
|
3749 Titer
Interval 2740.0 to 5131.0
|
5344 Titer
Interval 3809.0 to 7498.0
|
6766 Titer
Interval 5585.0 to 8197.0
|
3617 Titer
Interval 2816.0 to 4645.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 19A
|
138 Titer
Interval 71.0 to 271.0
|
84 Titer
Interval 45.0 to 156.0
|
117 Titer
Interval 76.0 to 181.0
|
66 Titer
Interval 44.0 to 100.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 1
|
14 Titer
Interval 11.0 to 18.0
|
12 Titer
Interval 10.0 to 14.0
|
10 Titer
Interval 9.0 to 11.0
|
11 Titer
Interval 9.0 to 12.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 1
|
57 Titer
Interval 39.0 to 84.0
|
360 Titer
Interval 272.0 to 476.0
|
548 Titer
Interval 455.0 to 660.0
|
396 Titer
Interval 302.0 to 519.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 3
|
21 Titer
Interval 15.0 to 29.0
|
15 Titer
Interval 11.0 to 22.0
|
29 Titer
Interval 22.0 to 40.0
|
19 Titer
Interval 14.0 to 24.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 19A
|
1708 Titer
Interval 1192.0 to 2448.0
|
2640 Titer
Interval 1943.0 to 3587.0
|
2162 Titer
Interval 1786.0 to 2618.0
|
2212 Titer
Interval 1801.0 to 2717.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 19F
|
267 Titer
Interval 169.0 to 421.0
|
928 Titer
Interval 618.0 to 1394.0
|
1095 Titer
Interval 810.0 to 1479.0
|
551 Titer
Interval 401.0 to 757.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 23F
|
139 Titer
Interval 67.0 to 288.0
|
206 Titer
Interval 108.0 to 394.0
|
87 Titer
Interval 53.0 to 145.0
|
46 Titer
Interval 29.0 to 73.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 12F
|
38 Titer
Interval 29.0 to 50.0
|
37 Titer
Interval 27.0 to 50.0
|
48 Titer
Interval 38.0 to 60.0
|
46 Titer
Interval 36.0 to 59.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 12F
|
16924 Titer
Interval 13400.0 to 21376.0
|
13257 Titer
Interval 9463.0 to 18572.0
|
23860 Titer
Interval 19002.0 to 29959.0
|
20250 Titer
Interval 16861.0 to 24320.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 8
|
4758 Titer
Interval 3763.0 to 6016.0
|
4428 Titer
Interval 3467.0 to 5654.0
|
3870 Titer
Interval 3302.0 to 4535.0
|
3125 Titer
Interval 2680.0 to 3642.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 10A
|
92 Titer
Interval 60.0 to 141.0
|
275 Titer
Interval 160.0 to 472.0
|
745 Titer
Interval 519.0 to 1071.0
|
554 Titer
Interval 395.0 to 777.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 10A
|
10626 Titer
Interval 7825.0 to 14429.0
|
14345 Titer
Interval 10473.0 to 19649.0
|
21102 Titer
Interval 17238.0 to 25833.0
|
17417 Titer
Interval 14301.0 to 21214.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 3
|
80 Titer
Interval 62.0 to 103.0
|
150 Titer
Interval 116.0 to 195.0
|
155 Titer
Interval 135.0 to 178.0
|
105 Titer
Interval 88.0 to 124.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 4
|
42 Titer
Interval 24.0 to 75.0
|
34 Titer
Interval 19.0 to 62.0
|
43 Titer
Interval 27.0 to 67.0
|
34 Titer
Interval 22.0 to 51.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 4
|
563 Titer
Interval 342.0 to 927.0
|
1729 Titer
Interval 1188.0 to 2516.0
|
2328 Titer
Interval 1942.0 to 2789.0
|
2290 Titer
Interval 1822.0 to 2878.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 5
|
18 Titer
Interval 16.0 to 21.0
|
17 Titer
Interval 15.0 to 20.0
|
15 Titer
Interval 15.0 to 15.0
|
15 Titer
Interval 15.0 to 16.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 5
|
51 Titer
Interval 38.0 to 68.0
|
198 Titer
Interval 143.0 to 276.0
|
385 Titer
Interval 324.0 to 458.0
|
216 Titer
Interval 159.0 to 294.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype 6A
|
137 Titer
Interval 77.0 to 243.0
|
96 Titer
Interval 55.0 to 168.0
|
74 Titer
Interval 51.0 to 106.0
|
64 Titer
Interval 44.0 to 91.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 22F
|
22464 Titer
Interval 16840.0 to 29967.0
|
25573 Titer
Interval 18096.0 to 36141.0
|
33615 Titer
Interval 26198.0 to 43130.0
|
27922 Titer
Interval 22622.0 to 34463.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
Before Vaccination, Serotype: 33F
|
1154 Titer
Interval 861.0 to 1548.0
|
2179 Titer
Interval 1694.0 to 2804.0
|
3334 Titer
Interval 2847.0 to 3905.0
|
2895 Titer
Interval 2448.0 to 3424.0
|
|
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes Before and 1 Month After Vaccination
1 Month after Vaccination, Serotype 33F
|
23431 Titer
Interval 17375.0 to 31598.0
|
28076 Titer
Interval 19255.0 to 40938.0
|
45921 Titer
Interval 36768.0 to 57353.0
|
32363 Titer
Interval 26219.0 to 39946.0
|
SECONDARY outcome
Timeframe: Before vaccination on Day 1 to 1 month after vaccinationPopulation: EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 56 days after vaccination for Cohorts 1-2; no other major protocol deviations. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants with valid assay results at both timepoints for the specified serotype.
Pneumococcal serotype-specific OPA titers were measured from serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution). OPA titers measured in a randomized subset of serum samples in Cohorts 1 and 2 for this outcome measure.
Outcome measures
| Measure |
Cohort 1: 20vPnC: >=15 to <24 Months
n=84 Participants
Participants aged greater than \>=15 months to \<24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 2: 20vPnC: >=2 to <5 Years
n=76 Participants
Participants aged \>=2 to \<5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 3: 20vPnC: >=5 to <10 Years
Participants aged \>=5 to \<10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
Cohort 4: 20vPnC: >=10 to <18 Years
Participants aged \>=10 to \<18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
|---|---|---|---|---|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2
Serotype 23F
|
12.5 Fold rise
Interval 6.7 to 23.6
|
10.7 Fold rise
Interval 6.2 to 18.5
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2
Serotype 8
|
155.9 Fold rise
Interval 110.4 to 220.2
|
105.4 Fold rise
Interval 67.6 to 164.3
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2
Serotype 10A
|
121.7 Fold rise
Interval 74.7 to 198.4
|
53.3 Fold rise
Interval 28.7 to 99.0
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2
Serotype 11A
|
161.4 Fold rise
Interval 115.7 to 225.2
|
34.7 Fold rise
Interval 17.1 to 70.4
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2
Serotype 12F
|
437.2 Fold rise
Interval 307.0 to 622.7
|
319.9 Fold rise
Interval 193.9 to 527.9
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2
Serotype 15B
|
717.6 Fold rise
Interval 449.8 to 1144.6
|
294.4 Fold rise
Interval 149.1 to 581.3
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2
Serotype 22F
|
983.6 Fold rise
Interval 580.9 to 1665.5
|
224.6 Fold rise
Interval 104.9 to 480.9
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2
Serotype 33F
|
18.8 Fold rise
Interval 13.1 to 27.2
|
12.4 Fold rise
Interval 7.4 to 20.7
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2
Serotype 3
|
3.7 Fold rise
Interval 2.6 to 5.3
|
9.6 Fold rise
Interval 7.1 to 13.1
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2
Serotype 1
|
4.1 Fold rise
Interval 2.9 to 6.0
|
29.8 Fold rise
Interval 21.2 to 41.9
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2
Serotype 4
|
13.2 Fold rise
Interval 7.0 to 25.0
|
50.0 Fold rise
Interval 26.7 to 93.6
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2
Serotype 5
|
2.8 Fold rise
Interval 2.0 to 3.8
|
11.4 Fold rise
Interval 8.2 to 16.0
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2
Serotype 6A
|
12.7 Fold rise
Interval 8.1 to 20.0
|
52.9 Fold rise
Interval 30.8 to 90.9
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2
Serotype 6B
|
7.8 Fold rise
Interval 4.6 to 13.2
|
24.4 Fold rise
Interval 14.4 to 41.2
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2
Serotype 7F
|
3.6 Fold rise
Interval 2.5 to 5.2
|
3.6 Fold rise
Interval 2.7 to 4.8
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2
Serotype 9V
|
11.5 Fold rise
Interval 6.2 to 21.3
|
23.1 Fold rise
Interval 14.7 to 36.5
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2
Serotype 14
|
3.9 Fold rise
Interval 2.5 to 6.1
|
8.3 Fold rise
Interval 5.1 to 13.4
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2
Serotype 18C
|
12.7 Fold rise
Interval 6.6 to 24.5
|
40.6 Fold rise
Interval 20.7 to 79.6
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2
Serotype 19A
|
11.1 Fold rise
Interval 6.2 to 19.8
|
33.5 Fold rise
Interval 17.3 to 65.0
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 1 and 2
Serotype 19F
|
5.7 Fold rise
Interval 3.3 to 9.7
|
21.0 Fold rise
Interval 13.0 to 33.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Before vaccination on Day 1 to 1 month after vaccinationPopulation: EIP included all participants who were eligible; received 20vPnC; at least 1 valid immunogenicity result from 1 month after vaccination collected within 27 to 49 days after vaccination for Cohorts 3-4; no other major protocol deviations. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and " Number Analyzed" signifies participants with valid assay results at both timepoints for the specified serotype.
Pneumococcal serotype-specific OPA titers were measured for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution). OPA titers for the 13vPnC serotypes were measured in a randomized subset of serum samples in Cohorts 3 and 4.
Outcome measures
| Measure |
Cohort 1: 20vPnC: >=15 to <24 Months
n=91 Participants
Participants aged greater than \>=15 months to \<24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 2: 20vPnC: >=2 to <5 Years
n=96 Participants
Participants aged \>=2 to \<5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 3: 20vPnC: >=5 to <10 Years
Participants aged \>=5 to \<10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
Cohort 4: 20vPnC: >=10 to <18 Years
Participants aged \>=10 to \<18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
|---|---|---|---|---|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4
Serotype 1
|
55.2 Fold rise
Interval 45.1 to 67.4
|
37.3 Fold rise
Interval 28.7 to 48.6
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4
Serotype 3
|
5.3 Fold rise
Interval 3.9 to 7.2
|
5.8 Fold rise
Interval 4.5 to 7.5
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4
Serotype 4
|
50.2 Fold rise
Interval 31.6 to 79.5
|
65.6 Fold rise
Interval 41.4 to 103.7
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4
Serotype 5
|
26.7 Fold rise
Interval 22.4 to 31.8
|
14.4 Fold rise
Interval 10.5 to 19.6
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4
Serotype 6A
|
110.3 Fold rise
Interval 68.7 to 177.1
|
147.9 Fold rise
Interval 96.0 to 228.0
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4
Serotype 6B
|
38.8 Fold rise
Interval 22.7 to 66.3
|
42.0 Fold rise
Interval 26.1 to 67.6
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4
Serotype 7F
|
7.0 Fold rise
Interval 5.3 to 9.3
|
6.2 Fold rise
Interval 4.4 to 8.8
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4
Serotype 9V
|
28.9 Fold rise
Interval 19.7 to 42.5
|
20.4 Fold rise
Interval 13.4 to 31.0
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4
Serotype 14
|
18.1 Fold rise
Interval 12.2 to 26.8
|
38.9 Fold rise
Interval 25.1 to 60.3
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4
Serotype 18C
|
46.2 Fold rise
Interval 26.8 to 79.6
|
47.3 Fold rise
Interval 28.7 to 78.0
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4
Serotype 19A
|
17.5 Fold rise
Interval 10.8 to 28.3
|
33.1 Fold rise
Interval 20.7 to 53.1
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4
Serotype 19F
|
11.7 Fold rise
Interval 7.4 to 18.5
|
10.0 Fold rise
Interval 6.7 to 15.0
|
—
|
—
|
|
GMFRs of Pneumococcal Serotype-Specific OPA Titers for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohorts 3 and 4
Serotype 23F
|
26.9 Fold rise
Interval 16.3 to 44.5
|
39.4 Fold rise
Interval 23.7 to 65.7
|
—
|
—
|
Adverse Events
Cohort 1: 20vPnC: >=15 to <24 Months
Serious events: 2 serious events
Other events: 173 other events
Deaths: 0 deaths
Cohort 2: 20vPnC: >=2 to <5 Years
Serious events: 0 serious events
Other events: 163 other events
Deaths: 0 deaths
Cohort 3: 20vPnC: >=5 to <10 Years
Serious events: 0 serious events
Other events: 178 other events
Deaths: 0 deaths
Cohort 4: 20vPnC: >=10 to <18 Years
Serious events: 3 serious events
Other events: 186 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: 20vPnC: >=15 to <24 Months
n=209 participants at risk
Participants aged greater than \>=15 months to \<24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 2: 20vPnC: >=2 to <5 Years
n=216 participants at risk
Participants aged \>=2 to \<5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 3: 20vPnC: >=5 to <10 Years
n=201 participants at risk
Participants aged \>=5 to \<10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
Cohort 4: 20vPnC: >=10 to <18 Years
n=205 participants at risk
Participants aged \>=10 to \<18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/209 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.00%
0/216 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.00%
0/201 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.49%
1/205 • Number of events 1 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.48%
1/209 • Number of events 1 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.00%
0/216 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.00%
0/201 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.00%
0/205 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/209 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.00%
0/216 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.00%
0/201 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.49%
1/205 • Number of events 1 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
|
Nervous system disorders
Headache
|
0.00%
0/209 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.00%
0/216 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.00%
0/201 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.49%
1/205 • Number of events 1 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
|
Nervous system disorders
Febrile convulsion
|
0.48%
1/209 • Number of events 1 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.00%
0/216 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.00%
0/201 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.00%
0/205 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
Other adverse events
| Measure |
Cohort 1: 20vPnC: >=15 to <24 Months
n=209 participants at risk
Participants aged greater than \>=15 months to \<24 months who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 2: 20vPnC: >=2 to <5 Years
n=216 participants at risk
Participants aged \>=2 to \<5 years who have been previously vaccinated with at least 3 doses of 13vPnC, were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1. The last dose of 13vPnC must have been administered \>2 months before enrollment into the study.
|
Cohort 3: 20vPnC: >=5 to <10 Years
n=201 participants at risk
Participants aged \>=5 to \<10 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
Cohort 4: 20vPnC: >=10 to <18 Years
n=205 participants at risk
Participants aged \>=10 to \<18 years regardless of previous vaccination status were administered a single dose of 0.5 mL 20vPnC intramuscularly on Day 1.
|
|---|---|---|---|---|
|
General disorders
Injection site erythema (REDNESS)
|
36.8%
77/209 • Number of events 84 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
38.9%
84/216 • Number of events 86 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
36.8%
74/201 • Number of events 79 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
15.1%
31/205 • Number of events 32 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
|
General disorders
Injection site pain (PAIN)
|
51.2%
107/209 • Number of events 115 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
65.7%
142/216 • Number of events 157 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
82.1%
165/201 • Number of events 178 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
82.0%
168/205 • Number of events 175 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
|
General disorders
Injection site swelling (SWELLING)
|
21.5%
45/209 • Number of events 51 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
23.1%
50/216 • Number of events 54 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
26.9%
54/201 • Number of events 57 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
15.6%
32/205 • Number of events 34 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
|
General disorders
Pyrexia (FEVER)
|
11.5%
24/209 • Number of events 25 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
3.2%
7/216 • Number of events 9 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.50%
1/201 • Number of events 1 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.00%
0/205 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
|
Metabolism and nutrition disorders
Decreased appetite (DECREASED APPETITE)
|
24.4%
51/209 • Number of events 72 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.00%
0/216 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.00%
0/201 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.00%
0/205 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
0.00%
0/209 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
3.7%
8/216 • Number of events 9 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
6.5%
13/201 • Number of events 14 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
8.3%
17/205 • Number of events 17 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
0.00%
0/209 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
26.4%
57/216 • Number of events 63 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
38.8%
78/201 • Number of events 86 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
48.3%
99/205 • Number of events 108 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
|
Nervous system disorders
Headache (HEADACHE)
|
0.00%
0/209 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
5.6%
12/216 • Number of events 13 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
18.4%
37/201 • Number of events 45 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
29.3%
60/205 • Number of events 75 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
|
Nervous system disorders
Hypersomnia (INCREASED SLEEP)
|
40.7%
85/209 • Number of events 104 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.00%
0/216 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.00%
0/201 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.00%
0/205 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
|
Psychiatric disorders
Irritability (IRRITABILITY)
|
60.3%
126/209 • Number of events 170 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.00%
0/216 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.00%
0/201 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
0.00%
0/205 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
|
General disorders
Fatigue (FATIGUE)
|
0.00%
0/209 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
37.0%
80/216 • Number of events 98 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
27.9%
56/201 • Number of events 76 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
27.8%
57/205 • Number of events 66 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination; SAEs (non-systematic assessment): from Day 1 up to 6 months after vaccination and other AEs (non-systematic assessment): from Day1 up to 1 month after vaccination
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received 20vPnC and had safety follow-up after vaccination.
|
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 the 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