Trial Outcomes & Findings for Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults (NCT NCT03760146)
NCT ID: NCT03760146
Last Updated: 2021-12-02
Results Overview
Local reactions were recorded using an electronic 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
3902 participants
Primary outcome timeframe
Within 10 days after 20vPnC or 13vPnC
Results posted on
2021-12-02
Participant Flow
Participant milestones
| Measure |
Cohort 1: 20vPnC/Saline
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1514
|
1495
|
334
|
111
|
336
|
112
|
|
Overall Study
Evaluable 13-Matched Immunogenicity Population
|
1435
|
1420
|
0
|
0
|
0
|
0
|
|
Overall Study
Evaluable 7-Additional Immunogenicity Population
|
1433
|
1383
|
0
|
0
|
0
|
0
|
|
Overall Study
Vaccination 1
|
1507
|
1490
|
334
|
111
|
335
|
112
|
|
Overall Study
Vaccination 2
|
1461
|
1446
|
0
|
0
|
0
|
0
|
|
Overall Study
Safety Population
|
1507
|
1490
|
334
|
111
|
335
|
112
|
|
Overall Study
Evaluable-20 Immunogenicity Population
|
946
|
0
|
321
|
0
|
317
|
0
|
|
Overall Study
COMPLETED
|
1418
|
1417
|
323
|
109
|
319
|
104
|
|
Overall Study
NOT COMPLETED
|
96
|
78
|
11
|
2
|
17
|
8
|
Reasons for withdrawal
| Measure |
Cohort 1: 20vPnC/Saline
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
11
|
8
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
41
|
28
|
9
|
2
|
14
|
8
|
|
Overall Study
No longer met eligibility criteria
|
3
|
9
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
21
|
13
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
19
|
20
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults
Baseline characteristics by cohort
| Measure |
Cohort 1: 20vPnC/Saline
n=1507 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
n=1490 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
n=334 Participants
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
n=111 Participants
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
n=335 Participants
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
n=112 Participants
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Total
n=3889 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.6 Years
STANDARD_DEVIATION 4.82 • n=5 Participants
|
64.6 Years
STANDARD_DEVIATION 4.81 • n=7 Participants
|
54.9 Years
STANDARD_DEVIATION 2.77 • n=5 Participants
|
55.0 Years
STANDARD_DEVIATION 3.11 • n=4 Participants
|
34.0 Years
STANDARD_DEVIATION 8.77 • n=21 Participants
|
33.9 Years
STANDARD_DEVIATION 8.03 • n=8 Participants
|
60.0 Years
STANDARD_DEVIATION 11.15 • n=8 Participants
|
|
Sex: Female, Male
Female
|
897 Participants
n=5 Participants
|
879 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
214 Participants
n=21 Participants
|
77 Participants
n=8 Participants
|
2331 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
610 Participants
n=5 Participants
|
611 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
121 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
1558 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
167 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
387 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1324 Participants
n=5 Participants
|
1308 Participants
n=7 Participants
|
319 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
300 Participants
n=21 Participants
|
102 Participants
n=8 Participants
|
3454 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
48 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
58 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
177 Participants
n=5 Participants
|
212 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
480 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
1295 Participants
n=5 Participants
|
1237 Participants
n=7 Participants
|
278 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
274 Participants
n=21 Participants
|
101 Participants
n=8 Participants
|
3275 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
32 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Within 10 days after 20vPnC or 13vPnCPopulation: Safety population included all participants who received 1 dose of any of the following: 20vPnC, 13vPnC, PPSV23 or saline and had safety follow-up after any vaccination. Here, "Overall Number of Participants Analyzed" =number of participants with any electronic diary data after 20vPnC or 13vPnC.
Local reactions were recorded using an electronic 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 1: 20vPnC/Saline
n=1505 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
n=1483 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
n=331 Participants
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
n=111 Participants
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
n=335 Participants
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
n=112 Participants
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts
Redness: Moderate
|
2.8 percentage of participants
Interval 2.0 to 3.8
|
2.2 percentage of participants
Interval 1.5 to 3.1
|
2.7 percentage of participants
Interval 1.3 to 5.1
|
2.7 percentage of participants
Interval 0.6 to 7.7
|
5.4 percentage of participants
Interval 3.2 to 8.4
|
4.5 percentage of participants
Interval 1.5 to 10.1
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts
Redness: Severe
|
0.8 percentage of participants
Interval 0.4 to 1.4
|
0.2 percentage of participants
Interval 0.0 to 0.6
|
0.3 percentage of participants
Interval 0.0 to 1.7
|
0 percentage of participants
Interval 0.0 to 3.3
|
0.6 percentage of participants
Interval 0.1 to 2.1
|
0 percentage of participants
Interval 0.0 to 3.2
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts
Swelling: Moderate
|
2.4 percentage of participants
Interval 1.7 to 3.3
|
2.8 percentage of participants
Interval 2.0 to 3.8
|
3.0 percentage of participants
Interval 1.5 to 5.5
|
3.6 percentage of participants
Interval 1.0 to 9.0
|
4.5 percentage of participants
Interval 2.5 to 7.3
|
3.6 percentage of participants
Interval 1.0 to 8.9
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts
Pain at the injection site: Any
|
55.4 percentage of participants
Interval 52.9 to 57.9
|
54.1 percentage of participants
Interval 51.6 to 56.7
|
72.5 percentage of participants
Interval 67.4 to 77.2
|
69.4 percentage of participants
Interval 59.9 to 77.8
|
81.2 percentage of participants
Interval 76.6 to 85.2
|
82.1 percentage of participants
Interval 73.8 to 88.7
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts
Pain at the injection site: Moderate
|
9.9 percentage of participants
Interval 8.4 to 11.5
|
9.2 percentage of participants
Interval 7.7 to 10.8
|
17.8 percentage of participants
Interval 13.9 to 22.4
|
16.2 percentage of participants
Interval 9.9 to 24.4
|
38.2 percentage of participants
Interval 33.0 to 43.6
|
28.6 percentage of participants
Interval 20.4 to 37.9
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts
Pain at the injection site: Severe
|
0.2 percentage of participants
Interval 0.0 to 0.6
|
0.3 percentage of participants
Interval 0.1 to 0.8
|
1.2 percentage of participants
Interval 0.3 to 3.1
|
0.9 percentage of participants
Interval 0.0 to 4.9
|
0.3 percentage of participants
Interval 0.0 to 1.7
|
0.9 percentage of participants
Interval 0.0 to 4.9
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts
Redness: Any
|
7.3 percentage of participants
Interval 6.0 to 8.7
|
6.2 percentage of participants
Interval 5.0 to 7.6
|
8.2 percentage of participants
Interval 5.4 to 11.6
|
5.4 percentage of participants
Interval 2.0 to 11.4
|
9.0 percentage of participants
Interval 6.1 to 12.5
|
9.8 percentage of participants
Interval 5.0 to 16.9
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts
Redness: Mild
|
3.7 percentage of participants
Interval 2.8 to 4.8
|
3.8 percentage of participants
Interval 2.9 to 4.9
|
5.1 percentage of participants
Interval 3.0 to 8.1
|
2.7 percentage of participants
Interval 0.6 to 7.7
|
3.0 percentage of participants
Interval 1.4 to 5.4
|
5.4 percentage of participants
Interval 2.0 to 11.3
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts
Swelling: Any
|
7.5 percentage of participants
Interval 6.2 to 9.0
|
8.0 percentage of participants
Interval 6.6 to 9.5
|
8.8 percentage of participants
Interval 5.9 to 12.3
|
10.8 percentage of participants
Interval 5.7 to 18.1
|
11.6 percentage of participants
Interval 8.4 to 15.6
|
12.5 percentage of participants
Interval 7.0 to 20.1
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts
Swelling: Mild
|
4.8 percentage of participants
Interval 3.8 to 6.0
|
4.9 percentage of participants
Interval 3.8 to 6.1
|
5.7 percentage of participants
Interval 3.5 to 8.8
|
7.2 percentage of participants
Interval 3.2 to 13.7
|
7.2 percentage of participants
Interval 4.6 to 10.5
|
8.9 percentage of participants
Interval 4.4 to 15.8
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts
Swelling: Severe
|
0.3 percentage of participants
Interval 0.1 to 0.8
|
0.3 percentage of participants
Interval 0.1 to 0.7
|
0 percentage of participants
Interval 0.0 to 1.1
|
0 percentage of participants
Interval 0.0 to 3.3
|
0 percentage of participants
Interval 0.0 to 1.1
|
0 percentage of participants
Interval 0.0 to 3.2
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts
Pain at the injection site: Mild
|
45.3 percentage of participants
Interval 42.8 to 47.9
|
44.6 percentage of participants
Interval 42.1 to 47.2
|
53.5 percentage of participants
Interval 47.9 to 58.9
|
52.3 percentage of participants
Interval 42.6 to 61.8
|
42.7 percentage of participants
Interval 37.3 to 48.2
|
52.7 percentage of participants
Interval 43.0 to 62.2
|
PRIMARY outcome
Timeframe: Within 7 days after 20vPnC or 13vPnCPopulation: Safety population included all participants who received 1 dose of any of the following: 20vPnC, 13vPnC, PPSV23 or saline and had safety follow-up after any vaccination. Here, "Overall Number of Participants Analyzed" =number of participants with any electronic diary data after 20vPnC or 13vPnC.
Systemic events fever, fatigue, headache, muscle pain and joint pain were recorded by using an electronic diary. Fever was defined as greater than or equal to (\>=) 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 1: 20vPnC/Saline
n=1505 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
n=1483 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
n=331 Participants
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
n=111 Participants
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
n=335 Participants
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
n=112 Participants
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
Joint pain: Mild
|
6.9 percentage of participants
Interval 5.7 to 8.3
|
7.1 percentage of participants
Interval 5.9 to 8.6
|
10.6 percentage of participants
Interval 7.5 to 14.4
|
12.6 percentage of participants
Interval 7.1 to 20.3
|
6.3 percentage of participants
Interval 3.9 to 9.4
|
8.9 percentage of participants
Interval 4.4 to 15.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
Fever: >=38.0 degree C
|
0.9 percentage of participants
Interval 0.5 to 1.6
|
0.8 percentage of participants
Interval 0.4 to 1.4
|
1.5 percentage of participants
Interval 0.5 to 3.5
|
0.9 percentage of participants
Interval 0.0 to 4.9
|
1.2 percentage of participants
Interval 0.3 to 3.0
|
1.8 percentage of participants
Interval 0.2 to 6.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
Fever: >=38.0 degree C to 38.4 degree C
|
0.3 percentage of participants
Interval 0.1 to 0.7
|
0.4 percentage of participants
Interval 0.1 to 0.9
|
0.6 percentage of participants
Interval 0.1 to 2.2
|
0.9 percentage of participants
Interval 0.0 to 4.9
|
0.6 percentage of participants
Interval 0.1 to 2.1
|
0 percentage of participants
Interval 0.0 to 3.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
Fever: >38.4 degree C to 38.9 degree C
|
0.3 percentage of participants
Interval 0.1 to 0.7
|
0.2 percentage of participants
Interval 0.0 to 0.6
|
0.3 percentage of participants
Interval 0.0 to 1.7
|
0 percentage of participants
Interval 0.0 to 3.3
|
0.3 percentage of participants
Interval 0.0 to 1.7
|
0 percentage of participants
Interval 0.0 to 3.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
Fever: >38.9 degree C to 40.0 degree C
|
0.0 percentage of participants
Interval 0.0 to 0.4
|
0 percentage of participants
Interval 0.0 to 0.2
|
0.3 percentage of participants
Interval 0.0 to 1.7
|
0 percentage of participants
Interval 0.0 to 3.3
|
0.3 percentage of participants
Interval 0.0 to 1.7
|
1.8 percentage of participants
Interval 0.2 to 6.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
Fever: >40.0 degree C
|
0.3 percentage of participants
Interval 0.1 to 0.8
|
0.2 percentage of participants
Interval 0.0 to 0.6
|
0.3 percentage of participants
Interval 0.0 to 1.7
|
0 percentage of participants
Interval 0.0 to 3.3
|
0 percentage of participants
Interval 0.0 to 1.1
|
0 percentage of participants
Interval 0.0 to 3.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
Fatigue: Any
|
30.2 percentage of participants
Interval 27.9 to 32.6
|
30.7 percentage of participants
Interval 28.3 to 33.1
|
39.3 percentage of participants
Interval 34.0 to 44.8
|
36.0 percentage of participants
Interval 27.1 to 45.7
|
42.7 percentage of participants
Interval 37.3 to 48.2
|
43.8 percentage of participants
Interval 34.4 to 53.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
Fatigue: Mild
|
16.1 percentage of participants
Interval 14.3 to 18.1
|
17.5 percentage of participants
Interval 15.6 to 19.6
|
21.1 percentage of participants
Interval 16.9 to 25.9
|
18.0 percentage of participants
Interval 11.4 to 26.4
|
18.8 percentage of participants
Interval 14.8 to 23.4
|
20.5 percentage of participants
Interval 13.5 to 29.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
Fatigue: Moderate
|
12.8 percentage of participants
Interval 11.2 to 14.6
|
11.9 percentage of participants
Interval 10.3 to 13.7
|
17.2 percentage of participants
Interval 13.3 to 21.7
|
15.3 percentage of participants
Interval 9.2 to 23.4
|
22.1 percentage of participants
Interval 17.8 to 26.9
|
19.6 percentage of participants
Interval 12.7 to 28.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
Fatigue: Severe
|
1.2 percentage of participants
Interval 0.7 to 1.9
|
1.2 percentage of participants
Interval 0.7 to 1.9
|
0.9 percentage of participants
Interval 0.2 to 2.6
|
2.7 percentage of participants
Interval 0.6 to 7.7
|
1.8 percentage of participants
Interval 0.7 to 3.9
|
3.6 percentage of participants
Interval 1.0 to 8.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
Headache: Any
|
21.5 percentage of participants
Interval 19.5 to 23.7
|
23.3 percentage of participants
Interval 21.1 to 25.5
|
32.3 percentage of participants
Interval 27.3 to 37.7
|
36.0 percentage of participants
Interval 27.1 to 45.7
|
38.8 percentage of participants
Interval 33.6 to 44.3
|
33.9 percentage of participants
Interval 25.3 to 43.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
Headache: Mild
|
15.5 percentage of participants
Interval 13.7 to 17.4
|
17.0 percentage of participants
Interval 15.1 to 19.0
|
20.5 percentage of participants
Interval 16.3 to 25.3
|
21.6 percentage of participants
Interval 14.4 to 30.4
|
21.5 percentage of participants
Interval 17.2 to 26.3
|
16.1 percentage of participants
Interval 9.8 to 24.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
Headache: Moderate
|
5.4 percentage of participants
Interval 4.3 to 6.6
|
5.9 percentage of participants
Interval 4.8 to 7.3
|
10.9 percentage of participants
Interval 7.7 to 14.7
|
13.5 percentage of participants
Interval 7.8 to 21.3
|
14.6 percentage of participants
Interval 11.0 to 18.9
|
17.0 percentage of participants
Interval 10.5 to 25.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
Headache: Severe
|
0.7 percentage of participants
Interval 0.3 to 1.2
|
0.3 percentage of participants
Interval 0.1 to 0.8
|
0.9 percentage of participants
Interval 0.2 to 2.6
|
0.9 percentage of participants
Interval 0.0 to 4.9
|
2.7 percentage of participants
Interval 1.2 to 5.0
|
0.9 percentage of participants
Interval 0.0 to 4.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
Muscle pain: Any
|
39.1 percentage of participants
Interval 36.6 to 41.6
|
37.3 percentage of participants
Interval 34.8 to 39.8
|
49.8 percentage of participants
Interval 44.3 to 55.4
|
49.5 percentage of participants
Interval 39.9 to 59.2
|
66.6 percentage of participants
Interval 61.2 to 71.6
|
74.1 percentage of participants
Interval 65.0 to 81.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
Muscle pain: Mild
|
28.9 percentage of participants
Interval 26.6 to 31.3
|
26.8 percentage of participants
Interval 24.6 to 29.2
|
33.8 percentage of participants
Interval 28.8 to 39.2
|
31.5 percentage of participants
Interval 23.0 to 41.0
|
36.4 percentage of participants
Interval 31.3 to 41.8
|
42.0 percentage of participants
Interval 32.7 to 51.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
Muscle pain: Moderate
|
9.8 percentage of participants
Interval 8.3 to 11.4
|
10.0 percentage of participants
Interval 8.5 to 11.6
|
15.4 percentage of participants
Interval 11.7 to 19.8
|
17.1 percentage of participants
Interval 10.6 to 25.4
|
29.0 percentage of participants
Interval 24.2 to 34.1
|
31.3 percentage of participants
Interval 22.8 to 40.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
Muscle pain: Severe
|
0.4 percentage of participants
Interval 0.1 to 0.9
|
0.5 percentage of participants
Interval 0.2 to 1.0
|
0.6 percentage of participants
Interval 0.1 to 2.2
|
0.9 percentage of participants
Interval 0.0 to 4.9
|
1.2 percentage of participants
Interval 0.3 to 3.0
|
0.9 percentage of participants
Interval 0.0 to 4.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
Joint pain: Any
|
12.6 percentage of participants
Interval 11.0 to 14.4
|
13.7 percentage of participants
Interval 12.0 to 15.5
|
15.4 percentage of participants
Interval 11.7 to 19.8
|
20.7 percentage of participants
Interval 13.6 to 29.5
|
13.4 percentage of participants
Interval 10.0 to 17.6
|
17.9 percentage of participants
Interval 11.3 to 26.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
Joint pain: Moderate
|
5.4 percentage of participants
Interval 4.3 to 6.6
|
6.3 percentage of participants
Interval 5.2 to 7.7
|
4.8 percentage of participants
Interval 2.8 to 7.7
|
7.2 percentage of participants
Interval 3.2 to 13.7
|
7.2 percentage of participants
Interval 4.6 to 10.5
|
8.0 percentage of participants
Interval 3.7 to 14.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
Joint pain: Severe
|
0.3 percentage of participants
Interval 0.1 to 0.8
|
0.2 percentage of participants
Interval 0.0 to 0.6
|
0 percentage of participants
Interval 0.0 to 1.1
|
0.9 percentage of participants
Interval 0.0 to 4.9
|
0 percentage of participants
Interval 0.0 to 1.1
|
0.9 percentage of participants
Interval 0.0 to 4.9
|
PRIMARY outcome
Timeframe: Within 1 month after 20vPnC or 13vPnCPopulation: Safety population included all participants who received 1 dose of any of the following: 20vPnC, 13vPnC, PPSV23 or saline and had safety follow-up after any 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 1: 20vPnC/Saline
n=1507 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
n=1490 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
n=334 Participants
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
n=111 Participants
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
n=335 Participants
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
n=112 Participants
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination in All Cohorts
|
9.8 percentage of participants
Interval 8.4 to 11.4
|
11.1 percentage of participants
Interval 9.6 to 12.8
|
10.2 percentage of participants
Interval 7.2 to 13.9
|
8.1 percentage of participants
Interval 3.8 to 14.8
|
15.2 percentage of participants
Interval 11.6 to 19.5
|
11.6 percentage of participants
Interval 6.3 to 19.0
|
PRIMARY outcome
Timeframe: Within 6 months after 20vPnC or 13vPnCPopulation: Safety population included all participants who received 1 dose of any of the following: 20vPnC, 13vPnC, PPSV23 or saline and had safety follow-up after any 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 1: 20vPnC/Saline
n=1507 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
n=1490 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
n=334 Participants
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
n=111 Participants
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
n=335 Participants
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
n=112 Participants
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination in All Cohorts
|
2.4 percentage of participants
Interval 1.7 to 3.3
|
1.9 percentage of participants
Interval 1.3 to 2.8
|
0.3 percentage of participants
Interval 0.0 to 1.7
|
0.9 percentage of participants
Interval 0.0 to 4.9
|
0.6 percentage of participants
Interval 0.1 to 2.1
|
0.9 percentage of participants
Interval 0.0 to 4.9
|
PRIMARY outcome
Timeframe: Within 6 months after 20vPnC or 13vPnCPopulation: Safety population included all participants who received 1 dose of any of the following: 20vPnC, 13vPnC, PPSV23 or saline and had safety follow-up after any 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 1: 20vPnC/Saline
n=1507 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
n=1490 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
n=334 Participants
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
n=111 Participants
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
n=335 Participants
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
n=112 Participants
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination in All Cohorts
|
2.3 percentage of participants
Interval 1.6 to 3.1
|
2.3 percentage of participants
Interval 1.6 to 3.3
|
1.5 percentage of participants
Interval 0.5 to 3.5
|
0.9 percentage of participants
Interval 0.0 to 4.9
|
1.5 percentage of participants
Interval 0.5 to 3.4
|
1.8 percentage of participants
Interval 0.2 to 6.3
|
PRIMARY outcome
Timeframe: 1 month after Vaccination 1Population: Evaluable 13-matched immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received Vaccination 1 as randomized, had at least 1 valid OPA titer for any of the 13 matched serotypes from the blood collection 27 to 49 days after Vaccination 1, had no other major protocol deviations. Number analyzed=participants evaluable for this outcome measure at specified rows.
OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.
Outcome measures
| Measure |
Cohort 1: 20vPnC/Saline
n=1435 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
n=1420 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
|---|---|---|---|---|---|---|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 23F
|
276.5 titer
Interval 242.5 to 315.2
|
335.1 titer
Interval 294.4 to 381.4
|
—
|
—
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 1
|
123.4 titer
Interval 112.3 to 135.5
|
153.8 titer
Interval 140.2 to 168.8
|
—
|
—
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 3
|
40.7 titer
Interval 38.0 to 43.6
|
47.8 titer
Interval 44.7 to 51.2
|
—
|
—
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 4
|
508.7 titer
Interval 456.5 to 566.9
|
626.9 titer
Interval 563.5 to 697.4
|
—
|
—
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 5
|
91.6 titer
Interval 83.4 to 100.5
|
109.7 titer
Interval 100.1 to 120.3
|
—
|
—
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 6A
|
889.0 titer
Interval 795.0 to 994.1
|
1165.1 titer
Interval 1043.3 to 1301.0
|
—
|
—
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 6B
|
1115.2 titer
Interval 1003.1 to 1239.8
|
1341.3 titer
Interval 1208.5 to 1488.8
|
—
|
—
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 7F
|
968.8 titer
Interval 887.0 to 1058.3
|
1129.2 titer
Interval 1034.7 to 1232.4
|
—
|
—
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 9V
|
1455.5 titer
Interval 1317.5 to 1608.0
|
1567.8 titer
Interval 1420.5 to 1730.5
|
—
|
—
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 14
|
746.7 titer
Interval 679.0 to 821.2
|
746.7 titer
Interval 679.8 to 820.1
|
—
|
—
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 18C
|
1252.6 titer
Interval 1123.1 to 1397.0
|
1482.3 titer
Interval 1330.5 to 1651.5
|
—
|
—
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 19A
|
517.9 titer
Interval 472.2 to 568.0
|
645.3 titer
Interval 588.9 to 707.1
|
—
|
—
|
—
|
—
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 19F
|
265.8 titer
Interval 240.2 to 294.1
|
333.3 titer
Interval 301.5 to 368.3
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline"; 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23"Population: Evaluable 7-additional immunogenicity population: participants who were enrolled in the appropriate cohort based on age, received 20vPnC if randomized to 20vPnC/saline group or received both vaccinations if randomized to 13vPnC/PPSV23 group, had at least 1 valid OPA titers for any of the 7 additional serotypes from the blood collection 27 to 49 days after Vaccination 1 or Vaccination 2 respectively, had no other major protocol deviations. Number analyzed=participants evaluable at specified rows.
OPA GMTs were determined for serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.
Outcome measures
| Measure |
Cohort 1: 20vPnC/Saline
n=1433 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
n=1383 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
|---|---|---|---|---|---|---|
|
Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP)
Serotype 8
|
465.6 titer
Interval 422.5 to 513.1
|
848.1 titer
Interval 769.1 to 935.2
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP)
Serotype 10A
|
2007.6 titer
Interval 1808.0 to 2229.1
|
1079.9 titer
Interval 972.1 to 1199.7
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP)
Serotype 11A
|
4426.8 titer
Interval 3965.5 to 4941.8
|
2534.9 titer
Interval 2276.8 to 2822.3
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP)
Serotype 12F
|
2538.7 titer
Interval 2255.3 to 2857.7
|
1716.6 titer
Interval 1521.8 to 1936.3
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP)
Serotype 15B
|
2398.2 titer
Interval 2090.6 to 2751.2
|
768.5 titer
Interval 669.7 to 881.9
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP)
Serotype 22F
|
3666.2 titer
Interval 3244.4 to 4143.0
|
1846.2 titer
Interval 1636.6 to 2082.6
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP)
Serotype 33F
|
5125.9 titer
Interval 4611.3 to 5698.0
|
3720.6 titer
Interval 3356.2 to 4124.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after vaccinationPopulation: Evaluable-20 immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received the vaccination as randomized, had at least 1 valid OPA titer from the blood collection 27 to 49 days after 20vPnC, had no other major protocol deviations. Number analyzed=participants evaluable at specified rows.
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. OPA geometric mean and 2-sided 95% CIs were calculated.
Outcome measures
| Measure |
Cohort 1: 20vPnC/Saline
n=321 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
n=946 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
|---|---|---|---|---|---|---|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 1
|
135.9 titer
Interval 113.1 to 163.4
|
131.8 titer
Interval 117.2 to 148.3
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 3
|
43.3 titer
Interval 38.0 to 49.4
|
40.9 titer
Interval 37.6 to 44.5
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 5
|
84.6 titer
Interval 70.3 to 101.8
|
96.5 titer
Interval 85.8 to 108.6
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 6A
|
1203.9 titer
Interval 968.1 to 1497.1
|
997.1 titer
Interval 866.5 to 1147.5
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 6B
|
1502.7 titer
Interval 1228.2 to 1838.5
|
1199.0 titer
Interval 1054.3 to 1363.4
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 7F
|
1047.0 titer
Interval 884.0 to 1240.2
|
1173.0 titer
Interval 1052.9 to 1306.9
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 9V
|
1725.7 titer
Interval 1424.4 to 2090.6
|
1687.9 titer
Interval 1493.7 to 1907.3
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 14
|
926.2 titer
Interval 761.8 to 1126.0
|
742.3 titer
Interval 655.8 to 840.2
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 18C
|
1805.0 titer
Interval 1459.6 to 2232.2
|
1355.2 titer
Interval 1184.3 to 1550.7
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 19A
|
618.4 titer
Interval 519.9 to 735.5
|
600.3 titer
Interval 537.5 to 670.6
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 19F
|
286.7 titer
Interval 236.0 to 348.2
|
290.4 titer
Interval 256.4 to 329.0
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 23F
|
549.1 titer
Interval 425.4 to 708.9
|
327.5 titer
Interval 278.2 to 385.6
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 8
|
486.9 titer
Interval 400.6 to 591.9
|
502.3 titer
Interval 442.8 to 569.8
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 10A
|
2520.4 titer
Interval 2076.0 to 3060.0
|
2437.0 titer
Interval 2149.8 to 2762.5
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 11A
|
6416.9 titer
Interval 5131.9 to 8023.6
|
5248.9 titer
Interval 4564.5 to 6035.9
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 12F
|
3445.1 titer
Interval 2807.8 to 4227.1
|
3105.2 titer
Interval 2722.7 to 3541.4
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 15B
|
3355.9 titer
Interval 2582.0 to 4361.8
|
2873.7 titer
Interval 2438.1 to 3387.1
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 22F
|
3808.1 titer
Interval 2998.2 to 4836.8
|
4228.4 titer
Interval 3629.6 to 4926.0
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 33F
|
5571.3 titer
Interval 4495.7 to 6904.2
|
5445.2 titer
Interval 4749.2 to 6243.2
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 4
|
633.3 titer
Interval 513.9 to 780.4
|
577.9 titer
Interval 505.5 to 660.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after vaccinationPopulation: Evaluable-20 immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received the vaccination as randomized, had at least 1 valid OPA titer from the blood collection 27 to 49 days after 20vPnC, had no other major protocol deviations. Number analyzed=participants evaluable at specified rows.
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. OPA geometric mean and 2-sided 95% CIs were calculated.
Outcome measures
| Measure |
Cohort 1: 20vPnC/Saline
n=317 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
n=946 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
|---|---|---|---|---|---|---|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 4
|
1966.7 titer
Interval 1599.5 to 2418.3
|
594.5 titer
Interval 522.9 to 675.9
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 6A
|
3930.5 titer
Interval 3176.0 to 4864.4
|
1022.8 titer
Interval 896.1 to 1167.4
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 19F
|
654.8 titer
Interval 538.2 to 796.8
|
301.2 titer
Interval 266.7 to 340.1
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 1
|
162.6 titer
Interval 135.1 to 195.6
|
132.0 titer
Interval 117.7 to 148.1
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 3
|
42.1 titer
Interval 36.9 to 48.1
|
42.0 titer
Interval 38.7 to 45.7
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 5
|
107.9 titer
Interval 89.4 to 130.1
|
96.9 titer
Interval 86.2 to 109.0
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 6B
|
4260.0 titer
Interval 3461.3 to 5243.1
|
1250.4 titer
Interval 1102.3 to 1418.4
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 7F
|
1872.8 titer
Interval 1564.2 to 2242.4
|
1187.2 titer
Interval 1064.4 to 1324.2
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 9V
|
6041.4 titer
Interval 4962.5 to 7354.9
|
1726.7 titer
Interval 1529.2 to 1949.7
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 14
|
1848.4 titer
Interval 1514.7 to 2255.7
|
772.8 titer
Interval 684.7 to 872.3
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 18C
|
4460.5 titer
Interval 3584.6 to 5550.4
|
1395.3 titer
Interval 1220.9 to 1594.5
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 19A
|
1415.0 titer
Interval 1181.8 to 1694.2
|
611.3 titer
Interval 547.8 to 682.3
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 23F
|
1559.2 titer
Interval 1208.1 to 2012.2
|
324.5 titer
Interval 277.1 to 380.1
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 8
|
867.0 titer
Interval 709.7 to 1059.2
|
508.1 titer
Interval 448.8 to 575.3
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 10A
|
4157.3 titer
Interval 3410.9 to 5067.0
|
2569.7 titer
Interval 2274.0 to 2903.7
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 11A
|
7169.3 titer
Interval 5735.7 to 8961.1
|
5419.7 titer
Interval 4737.7 to 6199.7
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 12F
|
5875.4 titer
Interval 4719.8 to 7314.1
|
3074.5 titer
Interval 2697.9 to 3503.7
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 15B
|
4601.0 titer
Interval 3487.9 to 6069.4
|
3019.0 titer
Interval 2562.8 to 3556.4
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 22F
|
7568.2 titer
Interval 5927.4 to 9663.2
|
4482.5 titer
Interval 3862.7 to 5201.8
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
Serotype 33F
|
7976.9 titer
Interval 6341.7 to 10033.7
|
5693.2 titer
Interval 4970.1 to 6521.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before Vaccination 1 to 1 month after Vaccination 1Population: Evaluable 13-matched immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received Vaccination 1 as randomized, had at least 1 valid OPA titer for any of the 13 matched serotypes from the blood collection 27 to 49 days after Vaccination 1, had no other major protocol deviations. Number analyzed=participants evaluable with OPA titers available at both timepoints at the specified row.
OPA GMFR is the ratio of OPA GMT, 1 month after vaccination to before vaccination OPA GMT. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Outcome measures
| Measure |
Cohort 1: 20vPnC/Saline
n=1435 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
n=1420 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
|---|---|---|---|---|---|---|
|
Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 18C
|
33.8 fold rise
Interval 30.0 to 38.1
|
37.7 fold rise
Interval 33.5 to 42.5
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 19A
|
21.0 fold rise
Interval 19.0 to 23.3
|
25.9 fold rise
Interval 23.3 to 28.8
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 1
|
12.6 fold rise
Interval 11.5 to 13.8
|
15.4 fold rise
Interval 14.1 to 16.8
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 3
|
4.8 fold rise
Interval 4.5 to 5.2
|
5.8 fold rise
Interval 5.4 to 6.2
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 4
|
31.2 fold rise
Interval 27.8 to 34.9
|
39.3 fold rise
Interval 35.1 to 44.1
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 5
|
6.1 fold rise
Interval 5.6 to 6.6
|
7.2 fold rise
Interval 6.6 to 7.8
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 6A
|
34.3 fold rise
Interval 30.7 to 38.3
|
42.6 fold rise
Interval 38.2 to 47.5
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 6B
|
23.8 fold rise
Interval 21.3 to 26.6
|
26.5 fold rise
Interval 23.7 to 29.6
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 7F
|
12.2 fold rise
Interval 11.1 to 13.3
|
13.5 fold rise
Interval 12.3 to 14.8
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 9V
|
11.0 fold rise
Interval 9.9 to 12.2
|
12.5 fold rise
Interval 11.3 to 13.9
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 14
|
9.3 fold rise
Interval 8.3 to 10.3
|
8.3 fold rise
Interval 7.4 to 9.2
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 19F
|
8.6 fold rise
Interval 7.9 to 9.5
|
10.8 fold rise
Interval 9.8 to 11.9
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 23F
|
24.9 fold rise
Interval 22.0 to 28.1
|
30.7 fold rise
Interval 27.1 to 34.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From before Vaccination 1 to 1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline" or From before Vaccination 1 to 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23"Population: E7-AIP included participants who were enrolled in appropriate cohort based on age, received 20vPnC if randomized to 20vPnC/saline group or received both vaccinations if randomized to 13vPnC/PPSV23 group, had at least 1 valid OPA titers for any of 7 additional serotypes from blood collection 27 to 49 days after Vaccination 1 or Vaccination 2 respectively, had no other major protocol deviations. Number analyzed=participants evaluable with OPA titers available at both timepoints at specified row.
OPA GMFR is the ratio of OPA GMT, 1 month after vaccination to before vaccination OPA GMT. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F.
Outcome measures
| Measure |
Cohort 1: 20vPnC/Saline
n=1433 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
n=1383 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
|---|---|---|---|---|---|---|
|
Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population
Serotype 12F
|
72.4 fold rise
Interval 64.2 to 81.6
|
47.3 fold rise
Interval 41.4 to 54.1
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population
Serotype 8
|
22.1 fold rise
Interval 20.0 to 24.5
|
40.4 fold rise
Interval 36.6 to 44.7
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population
Serotype 10A
|
18.5 fold rise
Interval 16.5 to 20.6
|
10.1 fold rise
Interval 9.1 to 11.3
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population
Serotype 11A
|
9.3 fold rise
Interval 8.1 to 10.7
|
6.0 fold rise
Interval 5.3 to 6.9
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population
Serotype 15B
|
55.4 fold rise
Interval 47.7 to 64.4
|
18.2 fold rise
Interval 15.6 to 21.1
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population
Serotype 22F
|
78.5 fold rise
Interval 67.3 to 91.5
|
37.9 fold rise
Interval 32.7 to 43.9
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population
Serotype 33F
|
7.5 fold rise
Interval 6.7 to 8.5
|
5.7 fold rise
Interval 5.1 to 6.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before vaccination to 1 month after vaccinationPopulation: Evaluable-20 immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received the vaccination as randomized, had at least 1 valid OPA titer from the blood collection 27 to 49 days after 20vPnC, had no other major protocol deviations. Number analyzed=participants evaluable with OPA titers available at both timepoints at the specified row.
OPA GMFR is the ratio of OPA GMT, 1 month after vaccination to before vaccination OPA GMT. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs 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 1: 20vPnC/Saline
n=321 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
n=317 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
|---|---|---|---|---|---|---|
|
Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 1
|
14.4 fold rise
Interval 12.0 to 17.3
|
18.6 fold rise
Interval 16.0 to 21.8
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 9V
|
12.1 fold rise
Interval 9.9 to 14.7
|
35.1 fold rise
Interval 27.9 to 44.2
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 11A
|
10.4 fold rise
Interval 7.7 to 14.2
|
5.2 fold rise
Interval 3.9 to 6.9
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 12F
|
107.3 fold rise
Interval 85.8 to 134.1
|
171.1 fold rise
Interval 135.1 to 216.8
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 15B
|
72.1 fold rise
Interval 51.9 to 100.1
|
65.0 fold rise
Interval 44.8 to 94.4
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 3
|
5.1 fold rise
Interval 4.4 to 5.9
|
4.8 fold rise
Interval 4.2 to 5.5
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 4
|
43.4 fold rise
Interval 34.4 to 54.9
|
131.8 fold rise
Interval 106.4 to 163.4
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 5
|
5.9 fold rise
Interval 5.0 to 7.0
|
7.9 fold rise
Interval 6.7 to 9.4
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 6A
|
50.3 fold rise
Interval 40.2 to 63.0
|
146.5 fold rise
Interval 120.6 to 178.0
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 6B
|
31.7 fold rise
Interval 25.3 to 39.7
|
70.3 fold rise
Interval 55.7 to 88.7
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 7F
|
12.8 fold rise
Interval 10.7 to 15.4
|
19.7 fold rise
Interval 16.1 to 24.3
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 14
|
10.4 fold rise
Interval 8.3 to 13.0
|
14.6 fold rise
Interval 11.3 to 18.9
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 18C
|
48.3 fold rise
Interval 37.9 to 61.5
|
111.8 fold rise
Interval 86.8 to 143.8
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 19A
|
23.6 fold rise
Interval 19.2 to 29.1
|
39.1 fold rise
Interval 30.9 to 49.6
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 19F
|
9.2 fold rise
Interval 7.6 to 11.3
|
17.8 fold rise
Interval 14.7 to 21.6
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 23F
|
47.8 fold rise
Interval 37.2 to 61.3
|
118.2 fold rise
Interval 92.7 to 150.7
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 8
|
23.9 fold rise
Interval 19.3 to 29.6
|
34.6 fold rise
Interval 27.8 to 43.0
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 10A
|
17.9 fold rise
Interval 14.2 to 22.6
|
22.7 fold rise
Interval 17.8 to 29.0
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 22F
|
63.5 fold rise
Interval 44.8 to 90.1
|
69.3 fold rise
Interval 48.4 to 99.4
|
—
|
—
|
—
|
—
|
|
Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 33F
|
9.1 fold rise
Interval 7.1 to 11.7
|
7.5 fold rise
Interval 5.8 to 9.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before Vaccination 1 to 1 month after Vaccination 1Population: Evaluable 13-matched immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received Vaccination 1 as randomized, had at least 1 valid OPA titer for any of the 13 matched serotypes from the blood collection 27 to 49 days after Vaccination 1, had no other major protocol deviations. Number analyzed=participants evaluable for this outcome measure at specified rows.
Percentage of participants with a \>=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Outcome measures
| Measure |
Cohort 1: 20vPnC/Saline
n=1435 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
n=1420 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 1
|
72.1 percentage of participants
Interval 69.7 to 74.4
|
74.8 percentage of participants
Interval 72.4 to 77.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 3
|
56.1 percentage of participants
Interval 53.4 to 58.7
|
61.7 percentage of participants
Interval 59.1 to 64.2
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 4
|
75.5 percentage of participants
Interval 73.2 to 77.8
|
79.6 percentage of participants
Interval 77.4 to 81.7
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 5
|
55.6 percentage of participants
Interval 52.9 to 58.2
|
60.6 percentage of participants
Interval 58.0 to 63.2
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 6A
|
80.5 percentage of participants
Interval 78.3 to 82.5
|
84.0 percentage of participants
Interval 82.0 to 85.9
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 6B
|
75.7 percentage of participants
Interval 73.3 to 77.9
|
77.6 percentage of participants
Interval 75.3 to 79.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 7F
|
71.8 percentage of participants
Interval 69.3 to 74.1
|
72.3 percentage of participants
Interval 69.8 to 74.6
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 9V
|
67.7 percentage of participants
Interval 65.1 to 70.3
|
69.3 percentage of participants
Interval 66.7 to 71.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 14
|
58.2 percentage of participants
Interval 55.5 to 60.8
|
54.0 percentage of participants
Interval 51.3 to 56.6
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 18C
|
77.7 percentage of participants
Interval 75.4 to 79.8
|
79.6 percentage of participants
Interval 77.4 to 81.7
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 19A
|
73.6 percentage of participants
Interval 71.3 to 75.9
|
77.5 percentage of participants
Interval 75.2 to 79.7
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 19F
|
63.6 percentage of participants
Interval 61.1 to 66.2
|
66.9 percentage of participants
Interval 64.4 to 69.4
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 23F
|
70.6 percentage of participants
Interval 68.2 to 73.0
|
74.4 percentage of participants
Interval 72.0 to 76.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before Vaccination 1 to 1 month after Vaccination 1 for "Cohort 1: 20vPnC/Saline"; Before Vaccination 1 to 1 month after Vaccination 2 for "Cohort 1: 13vPnC/PPSV23"Population: E7-AIP included participants who were enrolled in appropriate cohort based on age, received 20vPnC if randomized to 20vPnC/saline group or received both vaccinations if randomized to 13vPnC/PPSV23 group, had at least 1 valid OPA titers for any of 7 additional serotypes from blood collection 27 to 49 days after Vaccination 1 or Vaccination 2 respectively, had no other major protocol deviations. Number analyzed= participants evaluable at specified rows.
Percentage of participants with a \>=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F.
Outcome measures
| Measure |
Cohort 1: 20vPnC/Saline
n=1433 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
n=1383 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP
Serotype 8
|
77.8 percentage of participants
Interval 75.5 to 80.0
|
86.8 percentage of participants
Interval 84.8 to 88.6
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP
Serotype 10A
|
75.5 percentage of participants
Interval 73.0 to 77.9
|
65.6 percentage of participants
Interval 62.8 to 68.4
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP
Serotype 11A
|
59.2 percentage of participants
Interval 56.0 to 62.3
|
51.9 percentage of participants
Interval 48.7 to 55.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP
Serotype 12F
|
87.4 percentage of participants
Interval 85.5 to 89.2
|
80.6 percentage of participants
Interval 78.1 to 82.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP
Serotype 15B
|
77.8 percentage of participants
Interval 75.3 to 80.1
|
63.8 percentage of participants
Interval 61.0 to 66.6
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP
Serotype 22F
|
82.7 percentage of participants
Interval 80.4 to 84.8
|
76.8 percentage of participants
Interval 74.3 to 79.2
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP
Serotype 33F
|
60.1 percentage of participants
Interval 57.0 to 63.1
|
55.5 percentage of participants
Interval 52.4 to 58.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before vaccination to 1 month after vaccinationPopulation: Evaluable-20 immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received the vaccination as randomized, had at least 1 valid OPA titer from the blood collection 27 to 49 days after 20vPnC, had no other major protocol deviations. Number analyzed =participants evaluable at specified rows.
Percentage of participants with a \>=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs 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 1: 20vPnC/Saline
n=321 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
n=317 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 1
|
74.9 percentage of participants
Interval 69.8 to 79.6
|
86.0 percentage of participants
Interval 81.7 to 89.7
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 3
|
59.0 percentage of participants
Interval 53.4 to 64.5
|
56.7 percentage of participants
Interval 51.0 to 62.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 4
|
84.2 percentage of participants
Interval 79.6 to 88.1
|
91.4 percentage of participants
Interval 87.6 to 94.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 5
|
54.8 percentage of participants
Interval 49.1 to 60.4
|
64.8 percentage of participants
Interval 59.2 to 70.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 6A
|
85.9 percentage of participants
Interval 81.5 to 89.6
|
96.7 percentage of participants
Interval 94.1 to 98.4
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 6B
|
78.9 percentage of participants
Interval 73.9 to 83.4
|
89.2 percentage of participants
Interval 85.0 to 92.5
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 7F
|
73.0 percentage of participants
Interval 67.6 to 77.9
|
76.1 percentage of participants
Interval 70.7 to 80.9
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 9V
|
73.6 percentage of participants
Interval 68.1 to 78.6
|
84.0 percentage of participants
Interval 79.2 to 88.1
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 14
|
62.3 percentage of participants
Interval 56.6 to 67.8
|
62.2 percentage of participants
Interval 56.4 to 67.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 18C
|
82.5 percentage of participants
Interval 77.8 to 86.5
|
87.3 percentage of participants
Interval 83.0 to 90.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 19A
|
80.0 percentage of participants
Interval 75.1 to 84.3
|
82.6 percentage of participants
Interval 77.8 to 86.7
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 19F
|
64.2 percentage of participants
Interval 58.7 to 69.5
|
78.4 percentage of participants
Interval 73.4 to 82.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 23F
|
81.2 percentage of participants
Interval 76.4 to 85.3
|
87.7 percentage of participants
Interval 83.5 to 91.1
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 8
|
79.4 percentage of participants
Interval 74.4 to 83.7
|
83.0 percentage of participants
Interval 78.3 to 87.1
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 10A
|
78.8 percentage of participants
Interval 73.4 to 83.5
|
78.8 percentage of participants
Interval 73.4 to 83.6
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 11A
|
61.0 percentage of participants
Interval 54.1 to 67.6
|
47.3 percentage of participants
Interval 40.5 to 54.1
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 12F
|
93.2 percentage of participants
Interval 89.6 to 95.9
|
93.7 percentage of participants
Interval 89.9 to 96.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 15B
|
82.5 percentage of participants
Interval 77.4 to 86.9
|
73.4 percentage of participants
Interval 67.4 to 78.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 22 F
|
80.5 percentage of participants
Interval 75.1 to 85.1
|
83.8 percentage of participants
Interval 78.5 to 88.2
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 33F
|
63.9 percentage of participants
Interval 57.4 to 70.1
|
60.6 percentage of participants
Interval 53.7 to 67.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after Vaccination 1Population: Evaluable 13-matched immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received Vaccination 1 as randomized, had at least 1 valid OPA titer for any of the 13 matched serotypes from the blood collection 27 to 49 days after Vaccination 1, had no other major protocol deviations. Number analyzed =participants evaluable for this outcome measure at specified rows.
The percentage of participants with OPA titers \>=LLOQ along with corresponding 2-sided 95% CIs were calculated 1 month after vaccination for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Outcome measures
| Measure |
Cohort 1: 20vPnC/Saline
n=1435 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
n=1420 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 18C
|
93.8 percentage of participants
Interval 92.4 to 95.0
|
94.7 percentage of participants
Interval 93.4 to 95.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 5
|
71.9 percentage of participants
Interval 69.5 to 74.3
|
76.0 percentage of participants
Interval 73.7 to 78.2
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 6A
|
88.9 percentage of participants
Interval 87.1 to 90.5
|
90.9 percentage of participants
Interval 89.2 to 92.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 1
|
85.0 percentage of participants
Interval 83.0 to 86.8
|
87.9 percentage of participants
Interval 86.1 to 89.5
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 3
|
84.2 percentage of participants
Interval 82.2 to 86.0
|
87.0 percentage of participants
Interval 85.2 to 88.7
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 4
|
91.1 percentage of participants
Interval 89.5 to 92.5
|
92.1 percentage of participants
Interval 90.5 to 93.4
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 6B
|
90.5 percentage of participants
Interval 88.9 to 92.0
|
91.6 percentage of participants
Interval 90.0 to 93.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 7F
|
89.1 percentage of participants
Interval 87.3 to 90.7
|
91.3 percentage of participants
Interval 89.7 to 92.7
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 9V
|
89.1 percentage of participants
Interval 87.4 to 90.7
|
90.3 percentage of participants
Interval 88.6 to 91.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 14
|
91.6 percentage of participants
Interval 90.0 to 93.0
|
93.5 percentage of participants
Interval 92.1 to 94.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 19A
|
96.3 percentage of participants
Interval 95.2 to 97.3
|
96.6 percentage of participants
Interval 95.5 to 97.5
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 19F
|
80.3 percentage of participants
Interval 78.1 to 82.3
|
81.5 percentage of participants
Interval 79.3 to 83.5
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
Serotype 23F
|
82.1 percentage of participants
Interval 80.0 to 84.1
|
83.7 percentage of participants
Interval 81.6 to 85.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline" or 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23"Population: E7-AIP included participants who were enrolled in appropriate cohort based on age, received 20vPnC if randomized to 20vPnC/saline group or received both vaccinations if randomized to 13vPnC/PPSV23 group, had at least 1 valid OPA titers for any of 7 additional serotypes from blood collection 27 to 49 days after Vaccination 1 or Vaccination 2 respectively, had no other major protocol deviations. Number analyzed= participants evaluable at specified rows.
The percentage of participants with OPA titers \>=LLOQ along with corresponding 2-sided 95% CIs were calculated 1 month after vaccination for pneumococcal serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F.
Outcome measures
| Measure |
Cohort 1: 20vPnC/Saline
n=1433 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
n=1383 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population
Serotype 8
|
92.9 percentage of participants
Interval 91.5 to 94.2
|
96.6 percentage of participants
Interval 95.5 to 97.5
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population
Serotype 10A
|
95.6 percentage of participants
Interval 94.3 to 96.6
|
88.9 percentage of participants
Interval 87.1 to 90.6
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population
Serotype 11A
|
97.7 percentage of participants
Interval 96.6 to 98.4
|
95.4 percentage of participants
Interval 94.0 to 96.5
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population
Serotype 12F
|
95.7 percentage of participants
Interval 94.4 to 96.7
|
89.3 percentage of participants
Interval 87.4 to 91.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population
Serotype 15B
|
94.1 percentage of participants
Interval 92.6 to 95.3
|
83.3 percentage of participants
Interval 81.1 to 85.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population
Serotype 22F
|
98.6 percentage of participants
Interval 97.8 to 99.2
|
94.5 percentage of participants
Interval 93.0 to 95.7
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population
Serotype 33F
|
96.4 percentage of participants
Interval 95.1 to 97.4
|
92.8 percentage of participants
Interval 91.2 to 94.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after vaccinationPopulation: Evaluable-20 immunogenicity population included participants who were enrolled in the appropriate cohort based on age, received the vaccination as randomized, had at least 1 valid OPA titer from the blood collection 27 to 49 days after 20vPnC, had no other major protocol deviations. Number analyzed =participants evaluable at specified rows.
The percentage of participants with OPA titers \>=LLOQ along with corresponding 2-sided 95% CIs were calculated 1 month after vaccination for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure were planned to be analyzed for the 20vPnC groups of Cohorts 2 and 3 only.
Outcome measures
| Measure |
Cohort 1: 20vPnC/Saline
n=321 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after Vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
n=317 Participants
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 4
|
94.0 percentage of participants
Interval 90.8 to 96.4
|
98.1 percentage of participants
Interval 95.9 to 99.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 12F
|
97.9 percentage of participants
Interval 95.6 to 99.2
|
98.5 percentage of participants
Interval 96.3 to 99.6
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 15B
|
95.8 percentage of participants
Interval 92.7 to 97.8
|
96.8 percentage of participants
Interval 94.0 to 98.5
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 22F
|
98.2 percentage of participants
Interval 95.9 to 99.4
|
99.6 percentage of participants
Interval 98.0 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 33F
|
95.9 percentage of participants
Interval 92.7 to 97.9
|
99.6 percentage of participants
Interval 97.8 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 1
|
87.2 percentage of participants
Interval 83.0 to 90.6
|
92.1 percentage of participants
Interval 88.5 to 94.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 3
|
87.4 percentage of participants
Interval 83.3 to 90.9
|
89.9 percentage of participants
Interval 86.0 to 93.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 5
|
72.8 percentage of participants
Interval 67.6 to 77.7
|
81.1 percentage of participants
Interval 76.3 to 85.2
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 6A
|
91.8 percentage of participants
Interval 88.2 to 94.6
|
99.7 percentage of participants
Interval 98.2 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 6B
|
95.3 percentage of participants
Interval 92.3 to 97.3
|
99.0 percentage of participants
Interval 97.2 to 99.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 7F
|
92.7 percentage of participants
Interval 89.2 to 95.3
|
93.9 percentage of participants
Interval 90.6 to 96.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 9V
|
92.6 percentage of participants
Interval 89.1 to 95.3
|
99.0 percentage of participants
Interval 97.2 to 99.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 14
|
94.9 percentage of participants
Interval 91.8 to 97.1
|
99.1 percentage of participants
Interval 97.3 to 99.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 18C
|
97.5 percentage of participants
Interval 95.1 to 98.9
|
98.1 percentage of participants
Interval 95.9 to 99.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 19A
|
98.7 percentage of participants
Interval 96.8 to 99.7
|
99.7 percentage of participants
Interval 98.2 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 19F
|
81.9 percentage of participants
Interval 77.2 to 85.9
|
95.2 percentage of participants
Interval 92.3 to 97.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 23F
|
89.3 percentage of participants
Interval 85.4 to 92.5
|
96.5 percentage of participants
Interval 93.8 to 98.2
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 8
|
92.4 percentage of participants
Interval 88.8 to 95.0
|
95.8 percentage of participants
Interval 92.8 to 97.7
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 10A
|
98.3 percentage of participants
Interval 96.1 to 99.4
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
Serotype 11A
|
97.0 percentage of participants
Interval 94.3 to 98.7
|
99.6 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1: 20vPnC/Saline
Serious events: 36 serious events
Other events: 1074 other events
Deaths: 1 deaths
Cohort 1: 13vPnC/PPSV23
Serious events: 29 serious events
Other events: 1063 other events
Deaths: 0 deaths
Cohort 2: 20vPnC
Serious events: 1 serious events
Other events: 281 other events
Deaths: 0 deaths
Cohort 2: 13vPnC
Serious events: 1 serious events
Other events: 91 other events
Deaths: 0 deaths
Cohort 3: 20vPnC
Serious events: 2 serious events
Other events: 302 other events
Deaths: 0 deaths
Cohort 3: 13vPnC
Serious events: 1 serious events
Other events: 107 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: 20vPnC/Saline
n=1507 participants at risk
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
n=1490 participants at risk
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
n=334 participants at risk
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
n=111 participants at risk
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
n=335 participants at risk
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
n=112 participants at risk
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.30%
1/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Cardiac disorders
Atrial fibrillation
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.13%
2/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Cardiac disorders
Coronary artery disease
|
0.20%
3/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Cardiac disorders
Myocardial infarction
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Cardiac disorders
Silent myocardial infarction
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
General disorders
Chest pain
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
General disorders
Hernia
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
General disorders
Non-cardiac chest pain
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Hepatobiliary disorders
Biloma
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Infections and infestations
Appendicitis
|
0.13%
2/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Infections and infestations
Arthritis infective
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Infections and infestations
Cellulitis
|
0.13%
2/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Infections and infestations
Erysipelas
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Investigations
Blood pressure increased
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.13%
2/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.13%
2/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Nervous system disorders
Ischaemic stroke
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Nervous system disorders
Syncope
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Product Issues
Device malfunction
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Psychiatric disorders
Completed suicide
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.13%
2/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Renal and urinary disorders
Haematuria
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Renal and urinary disorders
Renal failure
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.13%
2/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.07%
1/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.30%
1/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.07%
1/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.90%
1/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.30%
1/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.30%
1/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Infections and infestations
Herpes simplex meningitis
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.89%
1/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
Other adverse events
| Measure |
Cohort 1: 20vPnC/Saline
n=1507 participants at risk
Participants aged 60 years and above were randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of saline at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 1: 13vPnC/PPSV23
n=1490 participants at risk
Participants aged 60 years and above were randomized to receive a single dose of 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) at Vaccination 1 (Day 1) and a single dose of 0.5 mL intramuscular injection of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Vaccination 2 (28 to 42 days after vaccination 1).
|
Cohort 2: 20vPnC
n=334 participants at risk
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 2: 13vPnC
n=111 participants at risk
Participants aged 50 through 59 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
Cohort 3: 20vPnC
n=335 participants at risk
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC (Day 1).
|
Cohort 3: 13vPnC
n=112 participants at risk
Participants aged 18 through 49 years were randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC (Day 1).
|
|---|---|---|---|---|---|---|
|
General disorders
Fatigue (FATIGUE)
|
30.1%
454/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
30.5%
455/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
38.9%
130/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
36.0%
40/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
42.7%
143/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
43.8%
49/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
General disorders
Injection site erythema (REDNESS)
|
7.3%
110/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
6.2%
92/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
8.1%
27/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
5.4%
6/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
9.0%
30/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
9.8%
11/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
General disorders
Injection site pain (PAIN)
|
55.3%
834/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
53.9%
803/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
71.9%
240/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
69.4%
77/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
81.2%
272/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
82.1%
92/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
General disorders
Injection site swelling (SWELLING)
|
7.5%
113/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
7.9%
118/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
8.7%
29/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
10.8%
12/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
11.6%
39/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
12.5%
14/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
12.6%
190/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
13.6%
203/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
15.3%
51/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
20.7%
23/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
13.4%
45/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
17.9%
20/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
39.0%
588/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
37.1%
553/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
49.4%
165/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
49.5%
55/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
66.6%
223/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
74.1%
83/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Nervous system disorders
Headache (HEADACHE)
|
21.5%
324/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
23.2%
345/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
32.0%
107/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
36.0%
40/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
38.8%
130/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
33.9%
38/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
General disorders
Pyrexia (FEVER)
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
1.5%
5/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.90%
1/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
1.2%
4/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
1.8%
2/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
1.2%
4/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
2.7%
3/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
2.1%
7/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.89%
1/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
1.2%
4/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Infections and infestations
Influenza
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
2.1%
7/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.89%
1/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
1.8%
6/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
1.8%
2/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1507 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/1490 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/334 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.00%
0/111 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
0.30%
1/335 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
1.8%
2/112 • Local reactions: within 10 days after Vaccination 1 (systematic assessment), Systemic events: within 7 days after Vaccination 1 (systematic assessment), Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1
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 used for the analysis.
|
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