Trial Outcomes & Findings for Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age (NCT NCT03313037)
NCT ID: NCT03313037
Last Updated: 2019-12-26
Results Overview
Local reactions included pain at injection site, swelling and redness recorded by participants in an electronic diary (e-diary). 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 centimeter (cm), moderate: 5.5 to 10.0 cm and severe: greater than or equal to (\>=) 10.5 cm. Pain was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
444 participants
Primary outcome timeframe
within 10 days after Vaccination 1
Results posted on
2019-12-26
Participant Flow
Participant milestones
| Measure |
20vPnC Followed by Saline
Participants received a single 0.5 milliliter \[mL\] intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of saline 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
13vPnC Followed by PPSV23
Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
|---|---|---|
|
Overall Study
STARTED
|
222
|
222
|
|
Overall Study
Safety Population
|
221
|
222
|
|
Overall Study
Evaluable Immunogenicity Population(EIP)
|
210
|
208
|
|
Overall Study
COMPLETED
|
202
|
202
|
|
Overall Study
NOT COMPLETED
|
20
|
20
|
Reasons for withdrawal
| Measure |
20vPnC Followed by Saline
Participants received a single 0.5 milliliter \[mL\] intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of saline 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
13vPnC Followed by PPSV23
Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
1
|
|
Overall Study
Other
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
No longer meets eligibility criteria
|
1
|
7
|
|
Overall Study
Lost to Follow-up
|
9
|
8
|
|
Overall Study
Randomized but not treated
|
1
|
0
|
Baseline Characteristics
Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age
Baseline characteristics by cohort
| Measure |
20vPnC Followed by Saline
n=221 Participants
Participants received a single 0.5 milliliter \[mL\] intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of saline 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
13vPnC Followed by PPSV23
n=222 Participants
Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
Total
n=443 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.0 years
STANDARD_DEVIATION 1.40 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 1.41 • n=7 Participants
|
62.0 years
STANDARD_DEVIATION 1.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
248 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
192 Participants
n=5 Participants
|
195 Participants
n=7 Participants
|
387 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
169 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
334 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 10 days after Vaccination 1Population: Safety analysis set included all participants who had received 1 dose of 20vPnC or 13vPnC. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Local reactions included pain at injection site, swelling and redness recorded by participants in an electronic diary (e-diary). 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 centimeter (cm), moderate: 5.5 to 10.0 cm and severe: greater than or equal to (\>=) 10.5 cm. Pain was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.
Outcome measures
| Measure |
20vPnC Followed by Saline
n=220 Participants
Participants received a single 0.5 milliliter \[mL\] intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of saline 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
13vPnC Followed by PPSV23
n=222 Participants
Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
|---|---|---|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1
Swelling: Moderate
|
5.5 percentage of participants
Interval 2.8 to 9.3
|
3.6 percentage of participants
Interval 1.6 to 7.0
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1
Swelling: Severe
|
0 percentage of participants
Interval 0.0 to 1.7
|
0 percentage of participants
Interval 0.0 to 1.6
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1
Pain at injection site: Mild
|
46.8 percentage of participants
Interval 40.1 to 53.6
|
43.7 percentage of participants
Interval 37.1 to 50.5
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1
Pain at injection site: Moderate
|
10.9 percentage of participants
Interval 7.1 to 15.8
|
9.5 percentage of participants
Interval 6.0 to 14.1
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1
Redness: Mild
|
7.3 percentage of participants
Interval 4.2 to 11.5
|
3.6 percentage of participants
Interval 1.6 to 7.0
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1
Redness: Moderate
|
3.6 percentage of participants
Interval 1.6 to 7.0
|
3.2 percentage of participants
Interval 1.3 to 6.4
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1
Redness: Severe
|
0.5 percentage of participants
Interval 0.0 to 2.5
|
0 percentage of participants
Interval 0.0 to 1.6
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1
Swelling: Mild
|
7.7 percentage of participants
Interval 4.6 to 12.1
|
7.7 percentage of participants
Interval 4.5 to 12.0
|
|
Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1
Pain at injection site: Severe
|
0 percentage of participants
Interval 0.0 to 1.7
|
0.5 percentage of participants
Interval 0.0 to 2.5
|
PRIMARY outcome
Timeframe: within 7 days after Vaccination 1Population: Safety analysis set included all participants who had received 1 dose of 20vPnC or 13vPnC. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Systemic events included fever, fatigue, headache, muscle pain and joint pain, recorded by participants in an e-diary. Fever was categorized as: \>=38.0 degrees Celsius (C), \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as mild: no interference with activity, moderate: some interference with activity and severe: prevents daily routine activity.
Outcome measures
| Measure |
20vPnC Followed by Saline
n=220 Participants
Participants received a single 0.5 milliliter \[mL\] intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of saline 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
13vPnC Followed by PPSV23
n=222 Participants
Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >=38.0 degree C
|
0 percentage of participants
Interval 0.0 to 1.7
|
0.5 percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >=38.0 to 38.4 degree C
|
0 percentage of participants
Interval 0.0 to 1.7
|
0.5 percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >38.4 to 38.9 degree C
|
0 percentage of participants
Interval 0.0 to 1.7
|
0 percentage of participants
Interval 0.0 to 1.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >38.9 to 40.0 degree C
|
0 percentage of participants
Interval 0.0 to 1.7
|
0 percentage of participants
Interval 0.0 to 1.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >40.0 degree C
|
0 percentage of participants
Interval 0.0 to 1.7
|
0 percentage of participants
Interval 0.0 to 1.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Mild
|
19.1 percentage of participants
Interval 14.1 to 24.9
|
18.0 percentage of participants
Interval 13.2 to 23.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Moderate
|
11.4 percentage of participants
Interval 7.5 to 16.3
|
10.4 percentage of participants
Interval 6.7 to 15.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Severe
|
0.5 percentage of participants
Interval 0.0 to 2.5
|
1.8 percentage of participants
Interval 0.5 to 4.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Mild
|
16.8 percentage of participants
Interval 12.1 to 22.4
|
18.0 percentage of participants
Interval 13.2 to 23.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Moderate
|
3.6 percentage of participants
Interval 1.6 to 7.0
|
5.4 percentage of participants
Interval 2.8 to 9.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Severe
|
0.5 percentage of participants
Interval 0.0 to 2.5
|
0.9 percentage of participants
Interval 0.1 to 3.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Muscle pain: Moderate
|
10.5 percentage of participants
Interval 6.7 to 15.3
|
9.5 percentage of participants
Interval 6.0 to 14.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Muscle pain: Severe
|
0 percentage of participants
Interval 0.0 to 1.7
|
0 percentage of participants
Interval 0.0 to 1.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Joint pain: Mild
|
9.5 percentage of participants
Interval 6.0 to 14.2
|
8.1 percentage of participants
Interval 4.9 to 12.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Muscle pain: Mild
|
32.7 percentage of participants
Interval 26.6 to 39.4
|
27.0 percentage of participants
Interval 21.3 to 33.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Joint pain: Moderate
|
5.5 percentage of participants
Interval 2.8 to 9.3
|
5.9 percentage of participants
Interval 3.2 to 9.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Joint pain: Severe
|
0 percentage of participants
Interval 0.0 to 1.7
|
0.5 percentage of participants
Interval 0.0 to 2.5
|
PRIMARY outcome
Timeframe: within 1 month after Vaccination 1 (up to 35 days)Population: Safety analysis set included all participants who had received 1 dose of 20vPnC or 13vPnC.
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
20vPnC Followed by Saline
n=221 Participants
Participants received a single 0.5 milliliter \[mL\] intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of saline 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
13vPnC Followed by PPSV23
n=222 Participants
Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1
|
12.2 percentage of participants
Interval 8.2 to 17.3
|
13.1 percentage of participants
Interval 8.9 to 18.2
|
PRIMARY outcome
Timeframe: within 6 months after Vaccination 1 (up to 196 days)Population: Safety analysis set included all participants who had received 1 dose of 20vPnC or 13vPnC.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with either SAE or NDCMCs during the specified duration are reported.
Outcome measures
| Measure |
20vPnC Followed by Saline
n=221 Participants
Participants received a single 0.5 milliliter \[mL\] intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of saline 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
13vPnC Followed by PPSV23
n=222 Participants
Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination 1
|
5.4 percentage of participants
Interval 2.8 to 9.3
|
4.5 percentage of participants
Interval 2.2 to 8.1
|
PRIMARY outcome
Timeframe: within 12 months after Vaccination 1 (up to 378 days)Population: Safety analysis set included all participants who had received 1 dose of 20vPnC or 13vPnC.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with either SAE or NDCMCs during the specified duration are reported.
Outcome measures
| Measure |
20vPnC Followed by Saline
n=221 Participants
Participants received a single 0.5 milliliter \[mL\] intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of saline 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
13vPnC Followed by PPSV23
n=222 Participants
Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination 1
|
10.0 percentage of participants
Interval 6.3 to 14.7
|
6.3 percentage of participants
Interval 3.5 to 10.4
|
SECONDARY outcome
Timeframe: 1 month after Vaccination 1Population: EIP: participants with no major protocol deviations, received assigned vaccine, blood drawn within 27 to 49 days after Vaccination 1 or 2, had OPA titres for at least 1 serotype either 1 month after Vaccination 1 or 2. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.
Antibody-mediated serum OPA against the 13 common pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5\*LLOQ in the analysis.
Outcome measures
| Measure |
20vPnC Followed by Saline
n=210 Participants
Participants received a single 0.5 milliliter \[mL\] intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of saline 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
13vPnC Followed by PPSV23
n=208 Participants
Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
|---|---|---|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 6A
|
1907 Titer (1/dilution)
Interval 1492.7 to 2436.2
|
2440 Titer (1/dilution)
Interval 1848.9 to 3219.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 7F
|
1581 Titer (1/dilution)
Interval 1361.6 to 1836.0
|
1936 Titer (1/dilution)
Interval 1651.1 to 2269.6
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 9V
|
1164 Titer (1/dilution)
Interval 949.6 to 1428.0
|
1612 Titer (1/dilution)
Interval 1311.4 to 1981.4
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 14
|
1114 Titer (1/dilution)
Interval 905.0 to 1371.4
|
1282 Titer (1/dilution)
Interval 1017.4 to 1614.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 18C
|
1322 Titer (1/dilution)
Interval 1053.2 to 1658.9
|
1660 Titer (1/dilution)
Interval 1335.1 to 2064.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 19F
|
455 Titer (1/dilution)
Interval 349.2 to 592.2
|
738 Titer (1/dilution)
Interval 582.1 to 936.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 23F
|
408 Titer (1/dilution)
Interval 293.0 to 568.0
|
509 Titer (1/dilution)
Interval 377.3 to 687.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 1
|
302 Titer (1/dilution)
Interval 239.6 to 381.4
|
454 Titer (1/dilution)
Interval 352.6 to 584.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 3
|
51 Titer (1/dilution)
Interval 43.2 to 61.2
|
64 Titer (1/dilution)
Interval 54.1 to 76.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 4
|
876 Titer (1/dilution)
Interval 676.8 to 1134.7
|
1153 Titer (1/dilution)
Interval 883.3 to 1504.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 5
|
144 Titer (1/dilution)
Interval 113.3 to 183.2
|
215 Titer (1/dilution)
Interval 168.7 to 274.4
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 6B
|
2006 Titer (1/dilution)
Interval 1591.4 to 2527.5
|
2218 Titer (1/dilution)
Interval 1716.9 to 2865.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 19A
|
943 Titer (1/dilution)
Interval 783.5 to 1136.1
|
1137 Titer (1/dilution)
Interval 936.5 to 1379.4
|
SECONDARY outcome
Timeframe: 1 month after Vaccination 1 for 20vPnC followed by saline reporting group; 1 month after Vaccination 2 for 13vPnC followed by PPSV23 reporting groupPopulation: EIP: participants with no major protocol deviations, received assigned vaccine, blood drawn within 27 to 49 days after Vaccination 1 or 2, had OPA titres for at least 1 serotype either 1 month after Vaccination 1 or 2. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.
Antibody-mediated serum OPA against the 7 additional pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis.
Outcome measures
| Measure |
20vPnC Followed by Saline
n=210 Participants
Participants received a single 0.5 milliliter \[mL\] intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of saline 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
13vPnC Followed by PPSV23
n=208 Participants
Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
|---|---|---|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC
Serotype 12F
|
6571 Titer (1/dilution)
Interval 5022.2 to 8597.3
|
4290 Titer (1/dilution)
Interval 3190.8 to 5769.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC
Serotype 8
|
740 Titer (1/dilution)
Interval 598.0 to 915.7
|
1150 Titer (1/dilution)
Interval 944.4 to 1401.6
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC
Serotype 22F
|
6286 Titer (1/dilution)
Interval 5025.0 to 7863.2
|
3513 Titer (1/dilution)
Interval 2824.8 to 4367.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC
Serotype 10A
|
2604 Titer (1/dilution)
Interval 2096.4 to 3234.4
|
988 Titer (1/dilution)
Interval 731.2 to 1335.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC
Serotype 11A
|
3210 Titer (1/dilution)
Interval 2613.2 to 3943.8
|
3007 Titer (1/dilution)
Interval 2443.0 to 3700.3
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC
Serotype 15B
|
1889 Titer (1/dilution)
Interval 1434.7 to 2488.3
|
720 Titer (1/dilution)
Interval 530.8 to 975.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC
Serotype 33F
|
5584 Titer (1/dilution)
Interval 4374.1 to 7128.0
|
3940 Titer (1/dilution)
Interval 3136.2 to 4950.9
|
SECONDARY outcome
Timeframe: before Vaccination 1 to one month after Vaccination 1Population: EIP: participants with no major protocol deviations, received assigned vaccine, blood drawn within 27 to 49 days after Vaccination 1 or 2, had OPA titres for at least 1 serotype either 1 month after Vaccination 1 or 2. 'Number analyzed' = Number of participants with non-missing OPA results at both time points at specified rows.
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before Vaccination 1 to one month after Vaccination 1 were calculated as the mean of the difference of logarithmically transformed OPA results (after vaccination - before vaccination) and transform back to the original scale. GMFRs were calculated using data from participants with non-missing OPA results at both time points. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis.
Outcome measures
| Measure |
20vPnC Followed by Saline
n=210 Participants
Participants received a single 0.5 milliliter \[mL\] intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of saline 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
13vPnC Followed by PPSV23
n=208 Participants
Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
|---|---|---|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 3
|
6.0 fold rise
Interval 5.02 to 7.23
|
7.1 fold rise
Interval 5.85 to 8.6
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 4
|
37.8 fold rise
Interval 27.4 to 52.1
|
51.0 fold rise
Interval 36.04 to 72.27
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 5
|
8.3 fold rise
Interval 6.55 to 10.54
|
11.6 fold rise
Interval 9.09 to 14.86
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 6A
|
58.6 fold rise
Interval 44.15 to 77.73
|
68.6 fold rise
Interval 49.49 to 95.2
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 6B
|
29.6 fold rise
Interval 22.56 to 38.96
|
38.8 fold rise
Interval 28.52 to 52.66
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 7F
|
12.2 fold rise
Interval 9.86 to 15.22
|
15.8 fold rise
Interval 12.57 to 19.82
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 9V
|
7.7 fold rise
Interval 6.15 to 9.57
|
10.1 fold rise
Interval 7.95 to 12.74
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 14
|
8.5 fold rise
Interval 6.35 to 11.26
|
9.6 fold rise
Interval 7.2 to 12.89
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 18C
|
26.8 fold rise
Interval 19.96 to 35.85
|
35.2 fold rise
Interval 26.02 to 47.5
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 19A
|
23.3 fold rise
Interval 17.96 to 30.19
|
30.9 fold rise
Interval 23.7 to 40.37
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 23F
|
33.6 fold rise
Interval 24.19 to 46.54
|
39.8 fold rise
Interval 28.85 to 54.88
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 1
|
21.2 fold rise
Interval 16.96 to 26.6
|
33.5 fold rise
Interval 25.77 to 43.65
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC
Serotype 19F
|
11.8 fold rise
Interval 8.93 to 15.47
|
18.4 fold rise
Interval 14.19 to 23.87
|
SECONDARY outcome
Timeframe: before Vaccination 1 to 1 month after Vaccination 1 for 20vPnC followed by saline reporting group; before Vaccination 1 to 1 month after Vaccination 2 for 13vPnC followed by PPSV23 reporting groupPopulation: EIP: participants with no protocol deviations, received assigned vaccine, blood drawn within 27 to 49 days after Vaccination 1 or 2, had OPA titres for at least 1 serotype either 1 month after Vaccination 1 or 2. 'Number analyzed' = Number of Participants with non-missing OPA results at both time points at specified row.
GMFR for 7 additional pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F) from before Vaccination 1 to one month after either Vaccination 1 (20vPnC) or Vaccination 2 (PPSV23) were calculated as the mean of the difference of logarithmically transformed OPA results (after vaccination - before vaccination) and transform back to the original scale. GMFRs were calculated using data from participants with non-missing OPA results at both time points. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis.
Outcome measures
| Measure |
20vPnC Followed by Saline
n=210 Participants
Participants received a single 0.5 milliliter \[mL\] intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of saline 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
13vPnC Followed by PPSV23
n=208 Participants
Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
|---|---|---|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC
Serotype 8
|
37.1 fold rise
Interval 27.71 to 49.71
|
56.9 fold rise
Interval 42.9 to 75.46
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC
Serotype 12F
|
113.4 fold rise
Interval 81.47 to 157.9
|
77.0 fold rise
Interval 55.04 to 107.64
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC
Serotype 15B
|
57.1 fold rise
Interval 41.74 to 78.07
|
21.3 fold rise
Interval 15.3 to 29.71
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC
Serotype 10A
|
49.3 fold rise
Interval 35.18 to 68.95
|
17.1 fold rise
Interval 12.15 to 24.15
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC
Serotype 11A
|
11.2 fold rise
Interval 8.16 to 15.31
|
9.8 fold rise
Interval 7.41 to 13.06
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC
Serotype 22F
|
55.4 fold rise
Interval 38.88 to 79.01
|
20.3 fold rise
Interval 14.69 to 27.96
|
|
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC
Serotype 33F
|
14.0 fold rise
Interval 9.96 to 19.62
|
8.9 fold rise
Interval 6.67 to 11.84
|
Adverse Events
20vPnC Followed by Saline
Serious events: 9 serious events
Other events: 162 other events
Deaths: 0 deaths
13vPnC Followed by PPSV23
Serious events: 11 serious events
Other events: 164 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
20vPnC Followed by Saline
n=221 participants at risk
Participants received a single 0.5 milliliter \[mL\] intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of saline 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
13vPnC Followed by PPSV23
n=222 participants at risk
Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
General disorders
Chest pain
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Infections and infestations
Meningitis pneumococcal
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Infections and infestations
Septic shock
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spindle cell sarcoma
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.90%
2/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Nervous system disorders
Lacunar infarction
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Nervous system disorders
Seizure
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
Other adverse events
| Measure |
20vPnC Followed by Saline
n=221 participants at risk
Participants received a single 0.5 milliliter \[mL\] intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of saline 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
13vPnC Followed by PPSV23
n=222 participants at risk
Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
|---|---|---|
|
General disorders
Injection site pruritus
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Infections and infestations
Acute sinusitis
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.90%
2/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Infections and infestations
Bronchitis
|
0.90%
2/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Infections and infestations
Sinusitis
|
1.4%
3/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
7/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
2.3%
5/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
43.0%
95/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
36.5%
81/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Nervous system disorders
Dizziness
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Endocrine disorders
Hypothyroidism
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Gastrointestinal disorders
Dental caries
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
General disorders
Chest pain
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
General disorders
Fatigue
|
30.8%
68/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
30.2%
67/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
General disorders
Injection site hypersensitivity
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
General disorders
Injection site pain
|
57.5%
127/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
53.6%
119/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
General disorders
Pyrexia
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
General disorders
Swelling
|
13.1%
29/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
11.3%
25/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Infections and infestations
Gastroenteritis viral
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Infections and infestations
Laryngitis viral
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.90%
2/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Infections and infestations
Urinary tract infection
|
0.90%
2/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Infections and infestations
Vaginal infection
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.90%
2/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Metabolism and nutrition disorders
Gout
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.9%
33/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
14.4%
32/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Nervous system disorders
Headache
|
20.8%
46/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
24.3%
54/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Renal and urinary disorders
Haematuria
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.90%
2/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.45%
1/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.00%
0/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.90%
2/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
0.45%
1/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
|
General disorders
Erythema
|
11.3%
25/221 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
6.8%
15/222 • Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER