Trial Outcomes & Findings for Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Vaccine in Adults 65 Years of Age or Older With Prior Pneumococcal Vaccination (NCT NCT03835975)
NCT ID: NCT03835975
Last Updated: 2021-02-21
Results Overview
Local reactions were recorded using an electronic diary (e-diary). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and severe (\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
875 participants
Primary outcome timeframe
Within 10 days after vaccination
Results posted on
2021-02-21
Participant Flow
Participant milestones
| Measure |
Cohort A: 20vPnC
Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (\>=) 1 to less than or equal to (\<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.
|
Cohort A: 13vPnC
Participants with receipt of PPSV23, \>=1 to \<=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.
|
Cohort B: 20vPnC
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
Cohort B: PPSV23
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.
|
Cohort C: 20vPnC
Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose \>=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
253
|
122
|
248
|
127
|
125
|
|
Overall Study
Vaccinated
|
253
|
122
|
246
|
127
|
125
|
|
Overall Study
Safety Population
|
253
|
122
|
246
|
127
|
125
|
|
Overall Study
Evaluable Immunogenicity Population (for 20vPnC Cohorts)
|
247
|
0
|
243
|
0
|
121
|
|
Overall Study
COMPLETED
|
250
|
119
|
245
|
126
|
125
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort A: 20vPnC
Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (\>=) 1 to less than or equal to (\<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.
|
Cohort A: 13vPnC
Participants with receipt of PPSV23, \>=1 to \<=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.
|
Cohort B: 20vPnC
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
Cohort B: PPSV23
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.
|
Cohort C: 20vPnC
Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose \>=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
No longer met eligibility criteria
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Vaccine in Adults 65 Years of Age or Older With Prior Pneumococcal Vaccination
Baseline characteristics by cohort
| Measure |
Cohort A: 20vPnC
n=253 Participants
Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (\>=) 1 to less than or equal to (\<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.
|
Cohort A: 13vPnC
n=122 Participants
Participants with receipt of PPSV23, \>=1 to \<=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.
|
Cohort B: 20vPnC
n=248 Participants
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
Cohort B: PPSV23
n=127 Participants
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.
|
Cohort C: 20vPnC
n=125 Participants
Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose \>=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
Total
n=875 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.6 years
STANDARD_DEVIATION 3.88 • n=5 Participants
|
70.2 years
STANDARD_DEVIATION 4.09 • n=7 Participants
|
70.7 years
STANDARD_DEVIATION 5.70 • n=5 Participants
|
70.6 years
STANDARD_DEVIATION 5.73 • n=4 Participants
|
70.8 years
STANDARD_DEVIATION 4.26 • n=21 Participants
|
70.3 years
STANDARD_DEVIATION 4.84 • n=10 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
477 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
398 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
247 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
113 Participants
n=21 Participants
|
832 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
47 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
236 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
117 Participants
n=21 Participants
|
809 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Within 10 days after vaccinationPopulation: The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC and had safety follow-up after vaccination. Here, "Overall Number of Participants Analyzed" refers to number of participants with any e-diary data reported after vaccination in the safety population.
Local reactions were recorded using an electronic diary (e-diary). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and severe (\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Outcome measures
| Measure |
Cohort A: 20vPnC
n=253 Participants
Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (\>=) 1 to less than or equal to (\<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.
|
Cohort A: 13vPnC
n=121 Participants
Participants with receipt of PPSV23, \>=1 to \<=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.
|
Cohort B: 20vPnC
n=245 Participants
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
Cohort B: PPSV23
n=126 Participants
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.
|
Cohort C: 20vPnC
n=125 Participants
Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose \>=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Redness: Any
|
7.9 percentage of participants
Interval 4.9 to 11.9
|
2.5 percentage of participants
Interval 0.5 to 7.1
|
8.6 percentage of participants
Interval 5.4 to 12.8
|
12.7 percentage of participants
Interval 7.4 to 19.8
|
4.8 percentage of participants
Interval 1.8 to 10.2
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Redness: Mild
|
3.6 percentage of participants
Interval 1.6 to 6.6
|
1.7 percentage of participants
Interval 0.2 to 5.8
|
2.9 percentage of participants
Interval 1.2 to 5.8
|
4.8 percentage of participants
Interval 1.8 to 10.1
|
1.6 percentage of participants
Interval 0.2 to 5.7
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Redness: Moderate
|
3.2 percentage of participants
Interval 1.4 to 6.1
|
0.8 percentage of participants
Interval 0.0 to 4.5
|
5.3 percentage of participants
Interval 2.9 to 8.9
|
7.1 percentage of participants
Interval 3.3 to 13.1
|
3.2 percentage of participants
Interval 0.9 to 8.0
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Redness: Severe
|
1.2 percentage of participants
Interval 0.2 to 3.4
|
0 percentage of participants
Interval 0.0 to 3.0
|
0.4 percentage of participants
Interval 0.0 to 2.3
|
0.8 percentage of participants
Interval 0.0 to 4.3
|
0 percentage of participants
Interval 0.0 to 2.9
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Swelling: Any
|
9.9 percentage of participants
Interval 6.5 to 14.2
|
6.6 percentage of participants
Interval 2.9 to 12.6
|
9.4 percentage of participants
Interval 6.0 to 13.8
|
14.3 percentage of participants
Interval 8.7 to 21.6
|
4.0 percentage of participants
Interval 1.3 to 9.1
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Swelling: Mild
|
5.1 percentage of participants
Interval 2.8 to 8.6
|
6.6 percentage of participants
Interval 2.9 to 12.6
|
5.7 percentage of participants
Interval 3.2 to 9.4
|
6.3 percentage of participants
Interval 2.8 to 12.1
|
1.6 percentage of participants
Interval 0.2 to 5.7
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Swelling: Moderate
|
3.6 percentage of participants
Interval 1.6 to 6.6
|
0 percentage of participants
Interval 0.0 to 3.0
|
3.7 percentage of participants
Interval 1.7 to 6.9
|
7.1 percentage of participants
Interval 3.3 to 13.1
|
2.4 percentage of participants
Interval 0.5 to 6.9
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Swelling: Severe
|
1.2 percentage of participants
Interval 0.2 to 3.4
|
0 percentage of participants
Interval 0.0 to 3.0
|
0 percentage of participants
Interval 0.0 to 1.5
|
0.8 percentage of participants
Interval 0.0 to 4.3
|
0 percentage of participants
Interval 0.0 to 2.9
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Pain at the injection site: Any
|
50.2 percentage of participants
Interval 43.9 to 56.5
|
43.0 percentage of participants
Interval 34.0 to 52.3
|
61.2 percentage of participants
Interval 54.8 to 67.4
|
56.3 percentage of participants
Interval 47.2 to 65.2
|
52.8 percentage of participants
Interval 43.7 to 61.8
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Pain at the injection site: Mild
|
45.8 percentage of participants
Interval 39.6 to 52.2
|
38.8 percentage of participants
Interval 30.1 to 48.1
|
54.7 percentage of participants
Interval 48.2 to 61.0
|
40.5 percentage of participants
Interval 31.8 to 49.6
|
47.2 percentage of participants
Interval 38.2 to 56.3
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Pain at the injection site: Moderate
|
4.3 percentage of participants
Interval 2.2 to 7.6
|
3.3 percentage of participants
Interval 0.9 to 8.2
|
6.1 percentage of participants
Interval 3.5 to 9.9
|
14.3 percentage of participants
Interval 8.7 to 21.6
|
5.6 percentage of participants
Interval 2.3 to 11.2
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Pain at the injection site: Severe
|
0 percentage of participants
Interval 0.0 to 1.4
|
0.8 percentage of participants
Interval 0.0 to 4.5
|
0.4 percentage of participants
Interval 0.0 to 2.3
|
1.6 percentage of participants
Interval 0.2 to 5.6
|
0 percentage of participants
Interval 0.0 to 2.9
|
PRIMARY outcome
Timeframe: Within 7 days after vaccinationPopulation: The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC and had safety follow-up after vaccination. Here, "Overall Number of Participants Analyzed" refers to number of participants with any e-diary data reported after vaccination in the safety population.
Systemic events fever, fatigue, headache, muscle pain and joint pain were recorded by using an e-diary. Fever was defined as temperature \>=38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity).
Outcome measures
| Measure |
Cohort A: 20vPnC
n=253 Participants
Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (\>=) 1 to less than or equal to (\<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.
|
Cohort A: 13vPnC
n=121 Participants
Participants with receipt of PPSV23, \>=1 to \<=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.
|
Cohort B: 20vPnC
n=245 Participants
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
Cohort B: PPSV23
n=126 Participants
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.
|
Cohort C: 20vPnC
n=125 Participants
Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose \>=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint Pain: Moderate
|
2.0 percentage of participants
Interval 0.6 to 4.6
|
5.0 percentage of participants
Interval 1.8 to 10.5
|
4.1 percentage of participants
Interval 2.0 to 7.4
|
5.6 percentage of participants
Interval 2.3 to 11.1
|
4.0 percentage of participants
Interval 1.3 to 9.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Any
|
17.8 percentage of participants
Interval 13.3 to 23.1
|
18.2 percentage of participants
Interval 11.8 to 26.2
|
13.5 percentage of participants
Interval 9.5 to 18.4
|
21.4 percentage of participants
Interval 14.6 to 29.6
|
19.2 percentage of participants
Interval 12.7 to 27.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Mild
|
12.6 percentage of participants
Interval 8.8 to 17.4
|
12.4 percentage of participants
Interval 7.1 to 19.6
|
9.8 percentage of participants
Interval 6.4 to 14.2
|
20.6 percentage of participants
Interval 13.9 to 28.8
|
12.8 percentage of participants
Interval 7.5 to 20.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Moderate
|
4.7 percentage of participants
Interval 2.5 to 8.1
|
5.8 percentage of participants
Interval 2.4 to 11.6
|
3.7 percentage of participants
Interval 1.7 to 6.9
|
0.8 percentage of participants
Interval 0.0 to 4.3
|
5.6 percentage of participants
Interval 2.3 to 11.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Severe
|
0.4 percentage of participants
Interval 0.0 to 2.2
|
0 percentage of participants
Interval 0.0 to 3.0
|
0 percentage of participants
Interval 0.0 to 1.5
|
0 percentage of participants
Interval 0.0 to 2.9
|
0.8 percentage of participants
Interval 0.0 to 4.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle Pain: Any
|
32.0 percentage of participants
Interval 26.3 to 38.1
|
31.4 percentage of participants
Interval 23.3 to 40.5
|
33.9 percentage of participants
Interval 28.0 to 40.2
|
46.0 percentage of participants
Interval 37.1 to 55.1
|
37.6 percentage of participants
Interval 29.1 to 46.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle Pain: Mild
|
26.1 percentage of participants
Interval 20.8 to 32.0
|
24.0 percentage of participants
Interval 16.7 to 32.6
|
25.3 percentage of participants
Interval 20.0 to 31.2
|
31.7 percentage of participants
Interval 23.7 to 40.6
|
28.0 percentage of participants
Interval 20.3 to 36.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle Pain: Moderate
|
5.5 percentage of participants
Interval 3.1 to 9.1
|
5.0 percentage of participants
Interval 1.8 to 10.5
|
8.6 percentage of participants
Interval 5.4 to 12.8
|
11.9 percentage of participants
Interval 6.8 to 18.9
|
8.8 percentage of participants
Interval 4.5 to 15.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle Pain: Severe
|
0.4 percentage of participants
Interval 0.0 to 2.2
|
2.5 percentage of participants
Interval 0.5 to 7.1
|
0 percentage of participants
Interval 0.0 to 1.5
|
2.4 percentage of participants
Interval 0.5 to 6.8
|
0.8 percentage of participants
Interval 0.0 to 4.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint Pain: Any
|
6.7 percentage of participants
Interval 4.0 to 10.5
|
10.7 percentage of participants
Interval 5.8 to 17.7
|
11.8 percentage of participants
Interval 8.1 to 16.6
|
15.9 percentage of participants
Interval 10.0 to 23.4
|
16.8 percentage of participants
Interval 10.7 to 24.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint Pain: Mild
|
4.7 percentage of participants
Interval 2.5 to 8.1
|
5.0 percentage of participants
Interval 1.8 to 10.5
|
7.8 percentage of participants
Interval 4.7 to 11.8
|
10.3 percentage of participants
Interval 5.6 to 17.0
|
12.8 percentage of participants
Interval 7.5 to 20.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint Pain: Severe
|
0 percentage of participants
Interval 0.0 to 1.4
|
0.8 percentage of participants
Interval 0.0 to 4.5
|
0 percentage of participants
Interval 0.0 to 1.5
|
0 percentage of participants
Interval 0.0 to 2.9
|
0 percentage of participants
Interval 0.0 to 2.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >=38.0 degree C
|
0.8 percentage of participants
Interval 0.1 to 2.8
|
0 percentage of participants
Interval 0.0 to 3.0
|
0 percentage of participants
Interval 0.0 to 1.5
|
1.6 percentage of participants
Interval 0.2 to 5.6
|
0 percentage of participants
Interval 0.0 to 2.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >=38.0 degree C to 38.4 degree C
|
0.8 percentage of participants
Interval 0.1 to 2.8
|
0 percentage of participants
Interval 0.0 to 3.0
|
0 percentage of participants
Interval 0.0 to 1.5
|
0.8 percentage of participants
Interval 0.0 to 4.3
|
0 percentage of participants
Interval 0.0 to 2.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >38.4 degree C to 38.9 degree C
|
0 percentage of participants
Interval 0.0 to 1.4
|
0 percentage of participants
Interval 0.0 to 3.0
|
0 percentage of participants
Interval 0.0 to 1.5
|
0.8 percentage of participants
Interval 0.0 to 4.3
|
0 percentage of participants
Interval 0.0 to 2.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >38.9 degree C to 40.0 degree C
|
0 percentage of participants
Interval 0.0 to 1.4
|
0 percentage of participants
Interval 0.0 to 3.0
|
0 percentage of participants
Interval 0.0 to 1.5
|
0 percentage of participants
Interval 0.0 to 2.9
|
0 percentage of participants
Interval 0.0 to 2.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >40.0 degree C
|
0 percentage of participants
Interval 0.0 to 1.4
|
0 percentage of participants
Interval 0.0 to 3.0
|
0 percentage of participants
Interval 0.0 to 1.5
|
0 percentage of participants
Interval 0.0 to 2.9
|
0 percentage of participants
Interval 0.0 to 2.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Any
|
28.9 percentage of participants
Interval 23.4 to 34.9
|
22.3 percentage of participants
Interval 15.2 to 30.8
|
31.0 percentage of participants
Interval 25.3 to 37.2
|
33.3 percentage of participants
Interval 25.2 to 42.3
|
32.8 percentage of participants
Interval 24.7 to 41.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Mild
|
17.8 percentage of participants
Interval 13.3 to 23.1
|
9.9 percentage of participants
Interval 5.2 to 16.7
|
19.6 percentage of participants
Interval 14.8 to 25.1
|
19.8 percentage of participants
Interval 13.3 to 27.9
|
19.2 percentage of participants
Interval 12.7 to 27.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Moderate
|
11.1 percentage of participants
Interval 7.5 to 15.6
|
9.9 percentage of participants
Interval 5.2 to 16.7
|
10.2 percentage of participants
Interval 6.7 to 14.7
|
13.5 percentage of participants
Interval 8.1 to 20.7
|
12.0 percentage of participants
Interval 6.9 to 19.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Severe
|
0 percentage of participants
Interval 0.0 to 1.4
|
2.5 percentage of participants
Interval 0.5 to 7.1
|
1.2 percentage of participants
Interval 0.3 to 3.5
|
0 percentage of participants
Interval 0.0 to 2.9
|
1.6 percentage of participants
Interval 0.2 to 5.7
|
PRIMARY outcome
Timeframe: Within 1 month after vaccinationPopulation: The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC and had safety follow-up after vaccination.
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
Outcome measures
| Measure |
Cohort A: 20vPnC
n=253 Participants
Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (\>=) 1 to less than or equal to (\<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.
|
Cohort A: 13vPnC
n=122 Participants
Participants with receipt of PPSV23, \>=1 to \<=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.
|
Cohort B: 20vPnC
n=246 Participants
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
Cohort B: PPSV23
n=127 Participants
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.
|
Cohort C: 20vPnC
n=125 Participants
Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose \>=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
|
7.5 percentage of participants
Interval 4.6 to 11.5
|
9.0 percentage of participants
Interval 4.6 to 15.6
|
4.9 percentage of participants
Interval 2.5 to 8.4
|
11.0 percentage of participants
Interval 6.2 to 17.8
|
10.4 percentage of participants
Interval 5.7 to 17.1
|
PRIMARY outcome
Timeframe: Within 6 months after vaccinationPopulation: The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC and had safety follow-up after vaccination.
An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event.
Outcome measures
| Measure |
Cohort A: 20vPnC
n=253 Participants
Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (\>=) 1 to less than or equal to (\<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.
|
Cohort A: 13vPnC
n=122 Participants
Participants with receipt of PPSV23, \>=1 to \<=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.
|
Cohort B: 20vPnC
n=246 Participants
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
Cohort B: PPSV23
n=127 Participants
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.
|
Cohort C: 20vPnC
n=125 Participants
Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose \>=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
|
0.8 percentage of participants
Interval 0.1 to 2.8
|
1.6 percentage of participants
Interval 0.2 to 5.8
|
2.4 percentage of participants
Interval 0.9 to 5.2
|
1.6 percentage of participants
Interval 0.2 to 5.6
|
1.6 percentage of participants
Interval 0.2 to 5.7
|
PRIMARY outcome
Timeframe: Within 6 months after vaccinationPopulation: The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC 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.
Outcome measures
| Measure |
Cohort A: 20vPnC
n=253 Participants
Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (\>=) 1 to less than or equal to (\<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.
|
Cohort A: 13vPnC
n=122 Participants
Participants with receipt of PPSV23, \>=1 to \<=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.
|
Cohort B: 20vPnC
n=246 Participants
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
Cohort B: PPSV23
n=127 Participants
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.
|
Cohort C: 20vPnC
n=125 Participants
Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose \>=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
|
2.0 percentage of participants
Interval 0.6 to 4.6
|
0.8 percentage of participants
Interval 0.0 to 4.5
|
2.8 percentage of participants
Interval 1.2 to 5.8
|
2.4 percentage of participants
Interval 0.5 to 6.7
|
4.0 percentage of participants
Interval 1.3 to 9.1
|
PRIMARY outcome
Timeframe: 1 month after vaccinationPopulation: Evaluable immunogenicity population: All participants who received 20vPnC as randomized, enrolled in appropriate cohort based on prior vaccination history, had Visit 2 blood collection within 27 to 49 days after vaccination, had at least 1 valid and determinate OPA titer for any serotype for Visit 2, had no major protocol deviations. Data for this outcome measure were planned to be analyzed for 20vPnC groups of each cohort. Number Analyzed =number of participants evaluable for each serotypes.
OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution.
Outcome measures
| Measure |
Cohort A: 20vPnC
n=247 Participants
Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (\>=) 1 to less than or equal to (\<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.
|
Cohort A: 13vPnC
n=243 Participants
Participants with receipt of PPSV23, \>=1 to \<=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.
|
Cohort B: 20vPnC
n=121 Participants
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
Cohort B: PPSV23
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.
|
Cohort C: 20vPnC
Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose \>=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
|---|---|---|---|---|---|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 1
|
50.8 titer
Interval 41.6 to 62.0
|
115.3 titer
Interval 96.3 to 137.9
|
82.1 titer
Interval 61.2 to 110.1
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 3
|
31.1 titer
Interval 26.7 to 36.1
|
54.3 titer
Interval 46.9 to 62.8
|
39.3 titer
Interval 32.0 to 48.2
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 4
|
149.9 titer
Interval 118.2 to 190.1
|
334.9 titer
Interval 273.8 to 409.5
|
193.7 titer
Interval 143.2 to 262.0
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 5
|
62.8 titer
Interval 52.7 to 74.9
|
87.3 titer
Interval 73.2 to 104.2
|
83.5 titer
Interval 64.8 to 107.6
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 6A
|
748.7 titer
Interval 576.7 to 972.0
|
1080.9 titer
Interval 880.2 to 1327.4
|
1085.3 titer
Interval 796.9 to 1478.1
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 6B
|
727.3 titer
Interval 573.6 to 922.1
|
1159.4 titer
Interval 950.7 to 1413.8
|
1033.3 titer
Interval 754.6 to 1414.8
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 7F
|
378.1 titer
Interval 316.4 to 451.9
|
555.4 titer
Interval 466.8 to 660.9
|
345.8 titer
Interval 277.0 to 431.7
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 9V
|
550.3 titer
Interval 454.0 to 666.9
|
1085.0 titer
Interval 893.5 to 1317.5
|
723.4 titer
Interval 558.1 to 937.6
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 14
|
391.2 titer
Interval 314.6 to 486.3
|
664.9 titer
Interval 554.1 to 797.9
|
580.5 titer
Interval 433.7 to 777.0
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 18C
|
551.9 titer
Interval 445.1 to 684.4
|
845.9 titer
Interval 692.5 to 1033.1
|
621.2 titer
Interval 469.9 to 821.3
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 19A
|
238.6 titer
Interval 197.5 to 288.4
|
365.1 titer
Interval 303.0 to 440.0
|
340.6 titer
Interval 264.1 to 439.2
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 19F
|
159.0 titer
Interval 131.4 to 192.3
|
242.3 titer
Interval 199.4 to 294.3
|
217.7 titer
Interval 168.1 to 281.8
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 23F
|
151.6 titer
Interval 115.3 to 199.3
|
450.2 titer
Interval 357.8 to 566.4
|
292.6 titer
Interval 203.6 to 420.5
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 8
|
211.9 titer
Interval 172.0 to 261.0
|
602.9 titer
Interval 482.9 to 752.8
|
293.8 titer
Interval 220.0 to 392.4
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 10A
|
1012.1 titer
Interval 806.7 to 1269.8
|
2005.4 titer
Interval 1586.0 to 2535.7
|
1580.3 titer
Interval 1175.9 to 2123.8
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 11A
|
1473.2 titer
Interval 1192.4 to 1820.2
|
1908.2 titer
Interval 1541.5 to 2362.2
|
1566.6 titer
Interval 1140.7 to 2151.4
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 12F
|
1054.5 titer
Interval 822.0 to 1352.7
|
1763.4 titer
Interval 1371.8 to 2266.7
|
1401.2 titer
Interval 1001.8 to 1959.7
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 15B
|
647.1 titer
Interval 490.8 to 853.1
|
1479.5 titer
Interval 1093.0 to 2002.8
|
1066.9 titer
Interval 721.3 to 1578.1
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 22F
|
1772.8 titer
Interval 1354.7 to 2319.8
|
4156.5 titer
Interval 3243.8 to 5326.2
|
2717.8 titer
Interval 1978.4 to 3733.4
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Serotype 33F
|
2026.2 titer
Interval 1684.3 to 2437.4
|
3174.9 titer
Interval 2579.1 to 3908.3
|
2182.9 titer
Interval 1638.6 to 2907.8
|
—
|
—
|
SECONDARY outcome
Timeframe: From before vaccination to 1 month after vaccinationPopulation: Evaluable immunogenicity population was analyzed. Data for this outcome measure were planned to be analyzed for 20vPnC groups of each cohort. Number analyzed= number of participants evaluable with OPA titers available at both time points for each serotype.
OPA GMFR is the ratio of OPA GMTs, 1 month after vaccination to before vaccination. OPA GMFRs from before to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Outcome measures
| Measure |
Cohort A: 20vPnC
n=247 Participants
Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (\>=) 1 to less than or equal to (\<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.
|
Cohort A: 13vPnC
n=243 Participants
Participants with receipt of PPSV23, \>=1 to \<=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.
|
Cohort B: 20vPnC
n=121 Participants
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
Cohort B: PPSV23
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.
|
Cohort C: 20vPnC
Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose \>=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
|---|---|---|---|---|---|
|
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 1
|
2.2 fold rise
Interval 1.9 to 2.5
|
3.4 fold rise
Interval 2.9 to 4.1
|
2.0 fold rise
Interval 1.7 to 2.4
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 3
|
2.4 fold rise
Interval 2.1 to 2.8
|
3.5 fold rise
Interval 3.1 to 4.1
|
1.9 fold rise
Interval 1.6 to 2.3
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 4
|
4.9 fold rise
Interval 3.9 to 6.1
|
5.0 fold rise
Interval 4.1 to 6.2
|
2.4 fold rise
Interval 1.9 to 3.1
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 5
|
2.3 fold rise
Interval 2.0 to 2.6
|
2.3 fold rise
Interval 2.0 to 2.6
|
1.8 fold rise
Interval 1.5 to 2.0
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 6A
|
12.6 fold rise
Interval 9.5 to 16.7
|
8.3 fold rise
Interval 6.6 to 10.4
|
6.5 fold rise
Interval 4.7 to 9.1
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 6B
|
6.6 fold rise
Interval 5.2 to 8.4
|
6.7 fold rise
Interval 5.4 to 8.3
|
4.0 fold rise
Interval 3.0 to 5.2
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 7F
|
2.3 fold rise
Interval 1.9 to 2.7
|
2.6 fold rise
Interval 2.2 to 3.0
|
1.6 fold rise
Interval 1.4 to 2.0
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 9V
|
2.4 fold rise
Interval 2.1 to 2.9
|
3.1 fold rise
Interval 2.6 to 3.6
|
2.1 fold rise
Interval 1.7 to 2.6
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 14
|
1.8 fold rise
Interval 1.5 to 2.1
|
2.3 fold rise
Interval 1.9 to 2.8
|
1.7 fold rise
Interval 1.4 to 2.1
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 18C
|
3.2 fold rise
Interval 2.5 to 3.9
|
3.9 fold rise
Interval 3.2 to 4.8
|
2.2 fold rise
Interval 1.8 to 2.7
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 19A
|
2.9 fold rise
Interval 2.4 to 3.4
|
2.9 fold rise
Interval 2.4 to 3.4
|
1.9 fold rise
Interval 1.6 to 2.2
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 19F
|
2.6 fold rise
Interval 2.2 to 3.1
|
2.7 fold rise
Interval 2.3 to 3.2
|
1.9 fold rise
Interval 1.5 to 2.3
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 23F
|
6.6 fold rise
Interval 5.1 to 8.5
|
9.3 fold rise
Interval 7.4 to 11.8
|
4.5 fold rise
Interval 3.4 to 6.0
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 8
|
3.6 fold rise
Interval 2.9 to 4.4
|
22.5 fold rise
Interval 17.2 to 29.4
|
2.1 fold rise
Interval 1.6 to 2.8
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 10A
|
4.5 fold rise
Interval 3.5 to 5.7
|
14.4 fold rise
Interval 10.9 to 19.0
|
4.4 fold rise
Interval 3.3 to 6.0
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 11A
|
2.5 fold rise
Interval 2.0 to 3.2
|
6.7 fold rise
Interval 5.0 to 9.0
|
3.1 fold rise
Interval 2.2 to 4.4
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 12F
|
7.2 fold rise
Interval 5.5 to 9.5
|
31.7 fold rise
Interval 23.1 to 43.4
|
3.8 fold rise
Interval 2.7 to 5.5
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 15B
|
4.3 fold rise
Interval 3.3 to 5.7
|
18.9 fold rise
Interval 13.0 to 27.4
|
4.8 fold rise
Interval 3.1 to 7.5
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 22F
|
11.1 fold rise
Interval 8.0 to 15.3
|
66.9 fold rise
Interval 46.5 to 96.4
|
9.8 fold rise
Interval 6.2 to 15.6
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Serotype 33F
|
1.8 fold rise
Interval 1.5 to 2.2
|
5.4 fold rise
Interval 4.2 to 6.8
|
1.8 fold rise
Interval 1.4 to 2.2
|
—
|
—
|
SECONDARY outcome
Timeframe: From before vaccination to 1 month after vaccinationPopulation: Evaluable immunogenicity population: All participants who received 20vPnC as randomized, enrolled in appropriate cohort based on prior vaccination history, had Visit 2 blood collection within 27 to 49 days after vaccination, had at least 1 valid and determinate OPA titer for any serotype for Visit 2, had no major protocol deviations. Data for this outcome measure were planned to be analyzed for 20vPnC groups of each cohort. Number Analyzed =number of participants evaluable for each serotype.
Percentage of participants with a \>=4-fold rise in pneumococcal OPA titers from before vaccination to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Outcome measures
| Measure |
Cohort A: 20vPnC
n=247 Participants
Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (\>=) 1 to less than or equal to (\<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.
|
Cohort A: 13vPnC
n=243 Participants
Participants with receipt of PPSV23, \>=1 to \<=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.
|
Cohort B: 20vPnC
n=121 Participants
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
Cohort B: PPSV23
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.
|
Cohort C: 20vPnC
Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose \>=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
|---|---|---|---|---|---|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Serotype 10A
|
45.5 percentage of participants
Interval 38.4 to 52.7
|
70.9 percentage of participants
Interval 64.0 to 77.1
|
44.0 percentage of participants
Interval 34.5 to 53.9
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Serotype 11A
|
30.4 percentage of participants
Interval 23.9 to 37.6
|
54.6 percentage of participants
Interval 47.1 to 62.0
|
35.2 percentage of participants
Interval 25.4 to 45.9
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Serotype 1
|
22.9 percentage of participants
Interval 17.8 to 28.6
|
40.3 percentage of participants
Interval 34.1 to 46.8
|
20.8 percentage of participants
Interval 14.0 to 29.2
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Serotype 3
|
29.6 percentage of participants
Interval 24.0 to 35.8
|
41.3 percentage of participants
Interval 35.0 to 47.8
|
18.5 percentage of participants
Interval 12.0 to 26.6
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Serotype 4
|
41.1 percentage of participants
Interval 34.7 to 47.8
|
41.3 percentage of participants
Interval 34.9 to 47.9
|
25.2 percentage of participants
Interval 17.6 to 34.2
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Serotype 5
|
25.7 percentage of participants
Interval 20.3 to 31.7
|
27.2 percentage of participants
Interval 21.7 to 33.2
|
15.8 percentage of participants
Interval 9.8 to 23.6
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Serotype 6A
|
61.5 percentage of participants
Interval 55.0 to 67.7
|
56.4 percentage of participants
Interval 49.8 to 62.9
|
44.9 percentage of participants
Interval 35.7 to 54.3
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Serotype 6B
|
53.4 percentage of participants
Interval 46.8 to 59.8
|
55.0 percentage of participants
Interval 48.5 to 61.5
|
35.3 percentage of participants
Interval 26.8 to 44.6
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Serotype 7F
|
26.2 percentage of participants
Interval 20.7 to 32.3
|
30.3 percentage of participants
Interval 24.6 to 36.5
|
14.3 percentage of participants
Interval 8.5 to 21.9
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Serotype 9V
|
28.3 percentage of participants
Interval 22.5 to 34.7
|
36.0 percentage of participants
Interval 29.7 to 42.6
|
20.2 percentage of participants
Interval 13.2 to 28.7
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Serotype 14
|
15.7 percentage of participants
Interval 11.3 to 21.0
|
24.9 percentage of participants
Interval 19.5 to 30.9
|
16.0 percentage of participants
Interval 9.9 to 23.8
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Serotype 18C
|
29.4 percentage of participants
Interval 23.8 to 35.5
|
38.3 percentage of participants
Interval 32.2 to 44.8
|
17.6 percentage of participants
Interval 11.3 to 25.7
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Serotype 19A
|
29.7 percentage of participants
Interval 24.0 to 35.9
|
29.3 percentage of participants
Interval 23.6 to 35.5
|
15.4 percentage of participants
Interval 9.4 to 23.2
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Serotype 19F
|
29.2 percentage of participants
Interval 23.6 to 35.4
|
32.8 percentage of participants
Interval 26.9 to 39.1
|
16.9 percentage of participants
Interval 10.7 to 25.0
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Serotype 23F
|
49.6 percentage of participants
Interval 43.1 to 56.1
|
58.7 percentage of participants
Interval 52.2 to 64.9
|
42.9 percentage of participants
Interval 33.8 to 52.3
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Serotype 8
|
39.9 percentage of participants
Interval 33.4 to 46.7
|
72.6 percentage of participants
Interval 66.2 to 78.4
|
30.7 percentage of participants
Interval 21.9 to 40.7
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Serotype 12F
|
51.4 percentage of participants
Interval 44.4 to 58.4
|
76.5 percentage of participants
Interval 70.0 to 82.2
|
40.8 percentage of participants
Interval 31.2 to 50.9
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Serotype 15B
|
37.4 percentage of participants
Interval 30.9 to 44.3
|
66.3 percentage of participants
Interval 59.0 to 73.1
|
38.4 percentage of participants
Interval 28.8 to 48.7
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Serotype 22F
|
57.0 percentage of participants
Interval 50.0 to 63.8
|
83.2 percentage of participants
Interval 77.2 to 88.2
|
54.8 percentage of participants
Interval 44.7 to 64.6
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Serotype 33F
|
18.7 percentage of participants
Interval 13.6 to 24.8
|
53.6 percentage of participants
Interval 46.3 to 60.7
|
19.2 percentage of participants
Interval 12.0 to 28.3
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after vaccinationPopulation: Evaluable immunogenicity population: All participants who received 20vPnC as randomized, enrolled in appropriate cohort based on prior vaccination history, had Visit 2 blood collection within 27 to 49 days after vaccination, had at least 1 valid and determinate OPA titer for any serotype for Visit 2, had no major protocol deviations. Data for this outcome measure were planned to be analyzed for 20vPnC groups of each cohort. Number Analyzed =number of participants evaluable for each serotype.
The percentage of participants with OPA titers \>=LLOQ at 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Outcome measures
| Measure |
Cohort A: 20vPnC
n=247 Participants
Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (\>=) 1 to less than or equal to (\<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.
|
Cohort A: 13vPnC
n=243 Participants
Participants with receipt of PPSV23, \>=1 to \<=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.
|
Cohort B: 20vPnC
n=121 Participants
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
Cohort B: PPSV23
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.
|
Cohort C: 20vPnC
Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose \>=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
Serotype 1
|
65.4 percentage of participants
Interval 59.1 to 71.4
|
87.7 percentage of participants
Interval 82.8 to 91.5
|
77.5 percentage of participants
Interval 69.0 to 84.6
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
Serotype 3
|
76.1 percentage of participants
Interval 70.3 to 81.3
|
90.5 percentage of participants
Interval 86.1 to 93.9
|
87.4 percentage of participants
Interval 80.1 to 92.8
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
Serotype 4
|
76.7 percentage of participants
Interval 70.8 to 81.9
|
91.7 percentage of participants
Interval 87.5 to 94.9
|
87.1 percentage of participants
Interval 79.6 to 92.6
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
Serotype 5
|
64.8 percentage of participants
Interval 58.4 to 70.7
|
74.9 percentage of participants
Interval 69.0 to 80.2
|
72.5 percentage of participants
Interval 63.6 to 80.3
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
Serotype 6A
|
84.3 percentage of participants
Interval 79.1 to 88.6
|
93.8 percentage of participants
Interval 89.9 to 96.5
|
90.9 percentage of participants
Interval 84.3 to 95.4
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
Serotype 6B
|
86.8 percentage of participants
Interval 81.9 to 90.8
|
93.8 percentage of participants
Interval 89.9 to 96.5
|
91.7 percentage of participants
Interval 85.3 to 96.0
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
Serotype 7F
|
74.2 percentage of participants
Interval 68.1 to 79.6
|
84.8 percentage of participants
Interval 79.6 to 89.0
|
79.2 percentage of participants
Interval 70.8 to 86.0
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
Serotype 9V
|
76.8 percentage of participants
Interval 70.9 to 81.9
|
89.5 percentage of participants
Interval 84.8 to 93.1
|
85.5 percentage of participants
Interval 77.8 to 91.3
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
Serotype 14
|
85.8 percentage of participants
Interval 80.8 to 90.0
|
95.0 percentage of participants
Interval 91.5 to 97.4
|
93.3 percentage of participants
Interval 87.2 to 97.1
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
Serotype 18C
|
91.8 percentage of participants
Interval 87.7 to 94.9
|
96.3 percentage of participants
Interval 93.0 to 98.3
|
95.8 percentage of participants
Interval 90.5 to 98.6
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
Serotype 19A
|
93.8 percentage of participants
Interval 90.0 to 96.5
|
95.9 percentage of participants
Interval 92.5 to 98.0
|
98.3 percentage of participants
Interval 94.1 to 99.8
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
Serotype 19F
|
71.7 percentage of participants
Interval 65.6 to 77.3
|
84.3 percentage of participants
Interval 79.1 to 88.6
|
84.7 percentage of participants
Interval 77.0 to 90.7
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
Serotype 23F
|
76.3 percentage of participants
Interval 70.5 to 81.5
|
93.8 percentage of participants
Interval 90.0 to 96.5
|
87.5 percentage of participants
Interval 80.2 to 92.8
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
Serotype 8
|
85.2 percentage of participants
Interval 80.0 to 89.5
|
94.7 percentage of participants
Interval 90.9 to 97.2
|
90.8 percentage of participants
Interval 83.8 to 95.5
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
Serotype 10A
|
92.2 percentage of participants
Interval 87.9 to 95.4
|
95.7 percentage of participants
Interval 92.0 to 98.0
|
96.4 percentage of participants
Interval 91.0 to 99.0
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
Serotype 11A
|
91.2 percentage of participants
Interval 86.6 to 94.6
|
94.7 percentage of participants
Interval 90.6 to 97.3
|
89.2 percentage of participants
Interval 81.5 to 94.5
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
Serotype 12F
|
87.9 percentage of participants
Interval 82.9 to 91.9
|
93.0 percentage of participants
Interval 88.7 to 96.0
|
91.8 percentage of participants
Interval 85.0 to 96.2
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
Serotype 15B
|
84.9 percentage of participants
Interval 79.5 to 89.3
|
91.0 percentage of participants
Interval 86.2 to 94.6
|
90.0 percentage of participants
Interval 82.8 to 94.9
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
Serotype 22F
|
94.0 percentage of participants
Interval 90.0 to 96.8
|
99.0 percentage of participants
Interval 96.5 to 99.9
|
98.1 percentage of participants
Interval 93.5 to 99.8
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
Serotype 33F
|
88.9 percentage of participants
Interval 83.9 to 92.7
|
91.8 percentage of participants
Interval 87.2 to 95.2
|
87.4 percentage of participants
Interval 79.4 to 93.1
|
—
|
—
|
Adverse Events
Cohort A: 20vPnC
Serious events: 2 serious events
Other events: 173 other events
Deaths: 0 deaths
Cohort A: 13vPnC
Serious events: 2 serious events
Other events: 69 other events
Deaths: 0 deaths
Cohort B: 20vPnC
Serious events: 6 serious events
Other events: 178 other events
Deaths: 0 deaths
Cohort B: PPSV23
Serious events: 2 serious events
Other events: 96 other events
Deaths: 0 deaths
Cohort C: 20vPnC
Serious events: 2 serious events
Other events: 86 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A: 20vPnC
n=253 participants at risk
Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (\>=) 1 to less than or equal to (\<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.
|
Cohort A: 13vPnC
n=122 participants at risk
Participants with receipt of PPSV23, \>=1 to \<=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.
|
Cohort B: 20vPnC
n=246 participants at risk
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
Cohort B: PPSV23
n=127 participants at risk
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.
|
Cohort C: 20vPnC
n=125 participants at risk
Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose \>=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.41%
1/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.40%
1/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.79%
1/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.41%
1/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.82%
1/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.79%
1/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.79%
1/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.80%
1/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
Investigations
Blood pressure decreased
|
0.00%
0/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.82%
1/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.79%
1/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.80%
1/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.41%
1/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.40%
1/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
Nervous system disorders
Syncope
|
0.00%
0/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.81%
2/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
0.00%
0/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.41%
1/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
Other adverse events
| Measure |
Cohort A: 20vPnC
n=253 participants at risk
Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (\>=) 1 to less than or equal to (\<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1.
|
Cohort A: 13vPnC
n=122 participants at risk
Participants with receipt of PPSV23, \>=1 to \<=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1.
|
Cohort B: 20vPnC
n=246 participants at risk
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
Cohort B: PPSV23
n=127 participants at risk
Participants with receipt of 13vPnC, \>=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1.
|
Cohort C: 20vPnC
n=125 participants at risk
Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose \>=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
|
|---|---|---|---|---|---|
|
General disorders
Fatigue (FATIGUE)
|
28.9%
73/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
22.1%
27/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
30.9%
76/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
33.1%
42/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
32.8%
41/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
General disorders
Injection site erythema (REDNESS)
|
7.9%
20/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
2.5%
3/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
8.5%
21/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
12.6%
16/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
4.8%
6/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
General disorders
Injection site pain (PAIN)
|
50.2%
127/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
42.6%
52/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
61.0%
150/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
55.9%
71/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
52.8%
66/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
General disorders
Injection site swelling (SWELLING)
|
9.9%
25/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
6.6%
8/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
9.3%
23/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
14.2%
18/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
4.0%
5/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
3/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.82%
1/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
1.6%
2/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
6.7%
17/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
10.7%
13/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
11.8%
29/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
15.7%
20/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
16.8%
21/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
32.0%
81/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
31.1%
38/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
33.7%
83/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
45.7%
58/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
37.6%
47/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
General disorders
Pyrexia (FEVER)
|
0.00%
0/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
1.6%
2/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.41%
1/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
1.6%
2/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
0.00%
0/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
|
Nervous system disorders
Headache (HEADACHE)
|
17.8%
45/253 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
18.0%
22/122 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
13.4%
33/246 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
21.3%
27/127 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
19.2%
24/125 • Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population was analyzed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER