Trial Outcomes & Findings for A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults (NCT NCT04816669)
NCT ID: NCT04816669
Last Updated: 2022-12-23
Results Overview
GMTs of full-length S-binding IgG level for lyophilized formulation in SDVs and frozen-Liquid formulation in MDVs were reported in this outcome measure as geometric mean concentration (GMCs) in descriptive data section. GMC and 95 percent (%) confidence interval (CI) were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. Geometric mean ratio (GMR) was calculated as ratios of GMCs of BNT162b2 30 mcg lyophilized SDV and frozen-liquid MDV. GMR are reported in the statistical analysis section.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
629 participants
Primary outcome timeframe
1 Month after Dose 2
Results posted on
2022-12-23
Participant Flow
This study was conducted in two parts: Part 1 and Part 2. Participants who received 2 doses of lyophilized formulation of BNT162b2 in Part 1, were offered to receive Dose 3 of frozen-liquid formulation.
Participant milestones
| Measure |
BNT162b2 Lyophilized Single Dose Vial (SDV): Part 1
Participants were randomized to receive 30 microgram (mcg) intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine. Participants after receiving 2 doses of lyophilized formulation of BNT162b2 and who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.
|
BNT162b2 Frozen-Liquid Multi Dose Vial (MDV): Part 1
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
|---|---|---|---|---|
|
Part 1
STARTED
|
279
|
280
|
0
|
0
|
|
Part 1
Vaccinated at Dose 1
|
279
|
280
|
0
|
0
|
|
Part 1
Vaccinated at Dose 2
|
276
|
277
|
0
|
0
|
|
Part 1
Vaccination at Dose 3
|
114
|
0
|
0
|
0
|
|
Part 1
COMPLETED
|
275
|
274
|
0
|
0
|
|
Part 1
NOT COMPLETED
|
4
|
6
|
0
|
0
|
|
Part 2
STARTED
|
0
|
0
|
35
|
35
|
|
Part 2
Vaccinated at Dose 1
|
0
|
0
|
35
|
35
|
|
Part 2
Vaccinated at Dose 2
|
0
|
0
|
35
|
35
|
|
Part 2
COMPLETED
|
0
|
0
|
33
|
34
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
BNT162b2 Lyophilized Single Dose Vial (SDV): Part 1
Participants were randomized to receive 30 microgram (mcg) intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine. Participants after receiving 2 doses of lyophilized formulation of BNT162b2 and who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.
|
BNT162b2 Frozen-Liquid Multi Dose Vial (MDV): Part 1
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
|---|---|---|---|---|
|
Part 1
Adverse Event
|
1
|
1
|
0
|
0
|
|
Part 1
Lost to Follow-up
|
2
|
2
|
0
|
0
|
|
Part 1
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Part 1
Withdrawal by Subject
|
1
|
2
|
0
|
0
|
|
Part 2
Other
|
0
|
0
|
1
|
0
|
|
Part 2
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Part 2
Lost to Follow-up
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults
Baseline characteristics by cohort
| Measure |
BNT162b2 Lyophilized SDV: Part 1
n=279 Participants
Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.
|
BNT162b2 Frozen-Liquid MDV: Part 1
n=280 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With LNP Size: Part 2
n=35 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With RTU Size: Part 2
n=35 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
Total
n=629 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
279 Participants
n=5 Participants
|
280 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
629 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
143 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
307 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
322 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
57 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
126 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
219 Participants
n=5 Participants
|
221 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
495 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
228 Participants
n=5 Participants
|
220 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
500 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 Month after Dose 2Population: Evaluable immunogenicity population: Participants who were eligible and randomized, received 2 doses of vaccine, with Dose 2 received within 19 to 42 days after Dose 1, had at least 1 valid immunogenicity result within 28 to 42 days after Dose 2, were negative for both SARS-CoV-2 tests at both Day 1 and 1 month post-Dose 2 visits, and had no other important protocol deviations as determined by clinician.
GMTs of full-length S-binding IgG level for lyophilized formulation in SDVs and frozen-Liquid formulation in MDVs were reported in this outcome measure as geometric mean concentration (GMCs) in descriptive data section. GMC and 95 percent (%) confidence interval (CI) were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. Geometric mean ratio (GMR) was calculated as ratios of GMCs of BNT162b2 30 mcg lyophilized SDV and frozen-liquid MDV. GMR are reported in the statistical analysis section.
Outcome measures
| Measure |
BNT162b2 Lyophilized SDV: Part 1
n=238 Participants
Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.
|
BNT162b2 Frozen-Liquid MDV: Part 1
n=226 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Full-Length S-Binding IgG Concentrations of Lyophilized Formulation SDVs and Frozen-Liquid Formulation in MDVs 1 Month After Dose 2
|
4796.8 Unit per milliliter
Interval 4414.1 to 5212.8
|
7031.6 Unit per milliliter
Interval 6393.6 to 7733.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 1Population: Safety population set included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after each vaccination.
Outcome measures
| Measure |
BNT162b2 Lyophilized SDV: Part 1
n=278 Participants
Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.
|
BNT162b2 Frozen-Liquid MDV: Part 1
n=280 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2
n=35 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2
n=35 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
|---|---|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Redness
|
4.0 Percentage of participants
Interval 2.0 to 7.0
|
5.0 Percentage of participants
Interval 2.8 to 8.2
|
0 Percentage of participants
Interval 0.0 to 10.0
|
2.9 Percentage of participants
Interval 0.1 to 14.9
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Swelling
|
3.6 Percentage of participants
Interval 1.7 to 6.5
|
3.6 Percentage of participants
Interval 1.7 to 6.5
|
0 Percentage of participants
Interval 0.0 to 10.0
|
5.7 Percentage of participants
Interval 0.7 to 19.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Pain at Injection Site
|
78.1 Percentage of participants
Interval 72.7 to 82.8
|
87.1 Percentage of participants
Interval 82.6 to 90.8
|
85.7 Percentage of participants
Interval 69.7 to 95.2
|
68.6 Percentage of participants
Interval 50.7 to 83.1
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 2Population: Safety population set included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after each vaccination.
Outcome measures
| Measure |
BNT162b2 Lyophilized SDV: Part 1
n=274 Participants
Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.
|
BNT162b2 Frozen-Liquid MDV: Part 1
n=274 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2
n=35 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2
n=35 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
|---|---|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 2
Redness
|
3.6 Percentage of participants
Interval 1.8 to 6.6
|
5.5 Percentage of participants
Interval 3.1 to 8.9
|
0 Percentage of participants
Interval 0.0 to 10.0
|
0 Percentage of participants
Interval 0.0 to 10.0
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 2
Swelling
|
2.9 Percentage of participants
Interval 1.3 to 5.7
|
3.3 Percentage of participants
Interval 1.5 to 6.1
|
0 Percentage of participants
Interval 0.0 to 10.0
|
8.6 Percentage of participants
Interval 1.8 to 23.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 2
Pain at Injection Site
|
71.2 Percentage of participants
Interval 65.4 to 76.5
|
80.3 Percentage of participants
Interval 75.1 to 84.8
|
71.4 Percentage of participants
Interval 53.7 to 85.4
|
62.9 Percentage of participants
Interval 44.9 to 78.5
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 1Population: Safety population set included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Systemic events were reported using an electronic diary. Fever was defined as temperature \>=38.0 degree Celsius (C). Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 1 were reported.
Outcome measures
| Measure |
BNT162b2 Lyophilized SDV: Part 1
n=278 Participants
Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.
|
BNT162b2 Frozen-Liquid MDV: Part 1
n=280 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2
n=35 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2
n=35 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
|---|---|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Fever >=38.0 degree C
|
0 Percentage of participants
Interval 0.0 to 1.3
|
3.2 Percentage of participants
Interval 1.5 to 6.0
|
0 Percentage of participants
Interval 0.0 to 10.0
|
0 Percentage of participants
Interval 0.0 to 10.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Fatigue
|
46.4 Percentage of participants
Interval 40.4 to 52.5
|
57.5 Percentage of participants
Interval 51.5 to 63.4
|
54.3 Percentage of participants
Interval 36.6 to 71.2
|
45.7 Percentage of participants
Interval 28.8 to 63.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Headache
|
31.3 Percentage of participants
Interval 25.9 to 37.1
|
44.3 Percentage of participants
Interval 38.4 to 50.3
|
37.1 Percentage of participants
Interval 21.5 to 55.1
|
31.4 Percentage of participants
Interval 16.9 to 49.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Chills
|
8.6 Percentage of participants
Interval 5.6 to 12.6
|
18.6 Percentage of participants
Interval 14.2 to 23.6
|
8.6 Percentage of participants
Interval 1.8 to 23.1
|
8.6 Percentage of participants
Interval 1.8 to 23.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Vomiting
|
2.9 Percentage of participants
Interval 1.3 to 5.6
|
2.1 Percentage of participants
Interval 0.8 to 4.6
|
5.7 Percentage of participants
Interval 0.7 to 19.2
|
2.9 Percentage of participants
Interval 0.1 to 14.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Diarrhea
|
14.4 Percentage of participants
Interval 10.5 to 19.1
|
13.9 Percentage of participants
Interval 10.1 to 18.5
|
5.7 Percentage of participants
Interval 0.7 to 19.2
|
11.4 Percentage of participants
Interval 3.2 to 26.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
New or worsened muscle pain
|
16.5 Percentage of participants
Interval 12.4 to 21.4
|
27.1 Percentage of participants
Interval 22.0 to 32.8
|
11.4 Percentage of participants
Interval 3.2 to 26.7
|
20.0 Percentage of participants
Interval 8.4 to 36.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
New or worsened joint pain
|
7.9 Percentage of participants
Interval 5.0 to 11.7
|
15.4 Percentage of participants
Interval 11.3 to 20.1
|
11.4 Percentage of participants
Interval 3.2 to 26.7
|
17.1 Percentage of participants
Interval 6.6 to 33.6
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 2Population: Safety population set included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Systemic events were reported using an electronic diary. Fever was defined as temperature \>=38.0 degree C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 2 were reported.
Outcome measures
| Measure |
BNT162b2 Lyophilized SDV: Part 1
n=274 Participants
Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.
|
BNT162b2 Frozen-Liquid MDV: Part 1
n=274 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2
n=35 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2
n=35 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
|---|---|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
New or worsened joint pain
|
16.8 Percentage of participants
Interval 12.6 to 21.8
|
32.1 Percentage of participants
Interval 26.6 to 38.0
|
11.4 Percentage of participants
Interval 3.2 to 26.7
|
28.6 Percentage of participants
Interval 14.6 to 46.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Fever >=38.0 degree C
|
6.2 Percentage of participants
Interval 3.7 to 9.7
|
12.4 Percentage of participants
Interval 8.7 to 16.9
|
2.9 Percentage of participants
Interval 0.1 to 14.9
|
5.7 Percentage of participants
Interval 0.7 to 19.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Fatigue
|
60.9 Percentage of participants
Interval 54.9 to 66.8
|
75.2 Percentage of participants
Interval 69.6 to 80.2
|
48.6 Percentage of participants
Interval 31.4 to 66.0
|
60.0 Percentage of participants
Interval 42.1 to 76.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Headache
|
48.2 Percentage of participants
Interval 42.1 to 54.3
|
61.7 Percentage of participants
Interval 55.6 to 67.5
|
40.0 Percentage of participants
Interval 23.9 to 57.9
|
40.0 Percentage of participants
Interval 23.9 to 57.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Chills
|
27.7 Percentage of participants
Interval 22.5 to 33.4
|
46.4 Percentage of participants
Interval 40.3 to 52.4
|
22.9 Percentage of participants
Interval 10.4 to 40.1
|
17.1 Percentage of participants
Interval 6.6 to 33.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Vomiting
|
3.6 Percentage of participants
Interval 1.8 to 6.6
|
2.2 Percentage of participants
Interval 0.8 to 4.7
|
2.9 Percentage of participants
Interval 0.1 to 14.9
|
0 Percentage of participants
Interval 0.0 to 10.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Diarrhea
|
12.8 Percentage of participants
Interval 9.1 to 17.3
|
14.6 Percentage of participants
Interval 10.6 to 19.3
|
8.6 Percentage of participants
Interval 1.8 to 23.1
|
14.3 Percentage of participants
Interval 4.8 to 30.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
New or worsened muscle pain
|
32.8 Percentage of participants
Interval 27.3 to 38.8
|
43.1 Percentage of participants
Interval 37.1 to 49.2
|
20.0 Percentage of participants
Interval 8.4 to 36.9
|
37.1 Percentage of participants
Interval 21.5 to 55.1
|
PRIMARY outcome
Timeframe: Dose 1 up to 1 Month after Dose 2 (for approximately 2 months)Population: Safety population set included all randomized participants who received at least 1 dose of the study intervention.
An AE was any untoward medical occurrence in a participant who received investigational product 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/birth defect or that was considered to be an important medical event. AEs included all non-SAEs and SAEs. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
BNT162b2 Lyophilized SDV: Part 1
n=279 Participants
Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.
|
BNT162b2 Frozen-Liquid MDV: Part 1
n=280 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2
n=35 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2
n=35 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2
AEs
|
16 Participants
|
21 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Before Dose 1 on Day 1)Population: Evaluable immunogenicity population: Participants who were eligible and randomized, received 2 doses of vaccine, with Dose 2 received within 19 to 42 days after Dose 1, had at least 1 valid immunogenicity result within 28 to 42 days after Dose 2, were negative for both SARS-CoV-2 tests at both Day 1 and 1 month post-Dose 2 visits, and had no other important protocol deviations as determined by clinician. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.
GMCs of full-length S-binding IgG levels were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
BNT162b2 Lyophilized SDV: Part 1
n=236 Participants
Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.
|
BNT162b2 Frozen-Liquid MDV: Part 1
n=226 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
|---|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline: Part 1
|
2.2 Unit per milliliter
Interval 1.8 to 2.6
|
2.2 Unit per milliliter
Interval 1.8 to 2.6
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Before Dose 1 on Day 1) up to 1 Month after Dose 2Population: Evaluable immunogenicity population: Participants who were eligible and randomized, received 2 doses of vaccine, with Dose 2 received within 19 to 42 days after Dose 1, had at least 1 valid immunogenicity result within 28 to 42 days after Dose 2, were negative for both SARS-CoV-2 tests at both Day 1 and 1 month post-Dose 2 visits, and had no other important protocol deviations as determined by clinician. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.
GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 2 to the geometric mean concentration of IgG at Baseline. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
BNT162b2 Lyophilized SDV: Part 1
n=236 Participants
Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.
|
BNT162b2 Frozen-Liquid MDV: Part 1
n=226 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
|---|---|---|---|---|
|
Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 1
|
2189.0 Fold rise
Interval 1841.6 to 2601.9
|
3194.0 Fold rise
Interval 2665.8 to 3826.8
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 Month after Dose 2Population: Evaluable immunogenicity population: Participants who were eligible and randomized, received 2 doses of vaccine, with Dose 2 received within 19 to 42 days after Dose 1, had at least 1 valid immunogenicity result within 28 to 42 days after Dose 2, were negative for both SARS-CoV-2 tests at both Day 1 and 1 month post-Dose 2 visits, and had no other important protocol deviations as determined by clinician.
GMTs of full-length S-binding IgG level for frozen liquid with LNP size at upper end of specification relative to frozen-liquid formulation in MDVs were reported in this outcome measure as GMCs in descriptive data section. GMC and 95 % CI were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. GMR was calculated as ratios of GMCs of BNT162b2 30 mcg frozen liquid with LNP size at upper end of specification relative to frozen-liquid formulation in MDVs. GMR are reported in the statistical analysis section.
Outcome measures
| Measure |
BNT162b2 Lyophilized SDV: Part 1
n=24 Participants
Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.
|
BNT162b2 Frozen-Liquid MDV: Part 1
n=28 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
|---|---|---|---|---|
|
GMTs of Full-Length S-Binding IgG Concentrations of Frozen Liquid With LNP Size at Upper End of Specification and Frozen-Liquid Formulation in MDVs 1 Month After Dose 2
|
7773.3 Unit per milliliter
Interval 5758.5 to 10493.1
|
6839.9 Unit per milliliter
Interval 5242.9 to 8923.5
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Before Dose 1 on Day 1), 1 Month after Dose 2Population: Evaluable immunogenicity population: Participants who were eligible and randomized, received 2 doses of vaccine, with Dose 2 received within 19 to 42 days after Dose 1, had at least 1 valid immunogenicity result within 28 to 42 days after Dose 2, were negative for both SARS-CoV-2 tests at both Day 1 and 1 month post-Dose 2 visits, and had no other important protocol deviations as determined by clinician.
GMCs of full-length S-binding IgG levels were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
BNT162b2 Lyophilized SDV: Part 1
n=24 Participants
Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.
|
BNT162b2 Frozen-Liquid MDV: Part 1
n=28 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
|---|---|---|---|---|
|
GMCs of Full-length S-binding IgG Levels at Baseline and 1 Month After Dose 2: Part 2
Baseline
|
2.3 Unit per milliliter
Interval 1.3 to 4.3
|
3.3 Unit per milliliter
Interval 1.6 to 6.7
|
—
|
—
|
|
GMCs of Full-length S-binding IgG Levels at Baseline and 1 Month After Dose 2: Part 2
1 Month after Dose 2
|
7773.3 Unit per milliliter
Interval 5758.5 to 10493.1
|
6839.9 Unit per milliliter
Interval 5242.9 to 8923.5
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Baseline (Before Dose 1 on Day 1) up to 1 Month after Dose 2Population: Evaluable immunogenicity population: Participants who were eligible and randomized, received 2 doses of vaccine, with Dose 2 received within 19 to 42 days after Dose 1, had at least 1 valid immunogenicity result within 28 to 42 days after Dose 2, were negative for both SARS-CoV-2 tests at both Day 1 and 1 month post-Dose 2 visits, and had no other important protocol deviations as determined by clinician.
GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 2 to the geometric mean concentration of IgG at Baseline. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
BNT162b2 Lyophilized SDV: Part 1
n=24 Participants
Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.
|
BNT162b2 Frozen-Liquid MDV: Part 1
n=28 Participants
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
|---|---|---|---|---|
|
GMFRs in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 2
|
3339.1 Fold rise
Interval 1662.6 to 6706.4
|
2072.1 Fold rise
Interval 987.5 to 4348.0
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after Dose 3Population: Safety population set included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 3.
Outcome measures
| Measure |
BNT162b2 Lyophilized SDV: Part 1
n=107 Participants
Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.
|
BNT162b2 Frozen-Liquid MDV: Part 1
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
|---|---|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Redness
|
6.5 Percentage of participants
Interval 2.7 to 13.0
|
—
|
—
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Swelling
|
6.5 Percentage of participants
Interval 2.7 to 13.0
|
—
|
—
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Pain at Injection Site
|
70.1 Percentage of participants
Interval 60.5 to 78.6
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days after Dose 3Population: Safety population set included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Systemic events were reported using an electronic diary. Fever was defined as temperature \>=38.0 degree Celsius (C). Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 3 were reported.
Outcome measures
| Measure |
BNT162b2 Lyophilized SDV: Part 1
n=107 Participants
Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.
|
BNT162b2 Frozen-Liquid MDV: Part 1
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
|---|---|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Fever >=38.0 degree C
|
8.4 Percentage of participants
Interval 3.9 to 15.4
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Fatigue
|
63.6 Percentage of participants
Interval 53.7 to 72.6
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Headache
|
52.3 Percentage of participants
Interval 42.5 to 62.1
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Chills
|
39.3 Percentage of participants
Interval 30.0 to 49.2
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Vomiting
|
2.8 Percentage of participants
Interval 0.6 to 8.0
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Diarrhea
|
13.1 Percentage of participants
Interval 7.3 to 21.0
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
New or worsened muscle pain
|
29.0 Percentage of participants
Interval 20.6 to 38.5
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
New or worsened joint pain
|
16.8 Percentage of participants
Interval 10.3 to 25.3
|
—
|
—
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Use of antipyretic or pain medication
|
35.5 Percentage of participants
Interval 26.5 to 45.4
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Dose 3 up to 1 Month after Dose 3 (1 month)Population: Safety population set included all randomized participants who received at least 1 dose of the study intervention.
An AE was any untoward medical occurrence in a participant who received investigational product 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/birth defect or that was considered to be an important medical event. AEs included all non-SAEs and SAEs. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
BNT162b2 Lyophilized SDV: Part 1
n=114 Participants
Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.
|
BNT162b2 Frozen-Liquid MDV: Part 1
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
|---|---|---|---|---|
|
Number of Participants With AEs and SAEs From Dose 3 to 1 Month After Dose 3
AEs
|
10 Participants
|
—
|
—
|
—
|
|
Number of Participants With AEs and SAEs From Dose 3 to 1 Month After Dose 3
SAEs
|
0 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From before Dose 3 to 1 Month after Dose 3Population: Evaluable immunogenicity population:Participants who were eligible and randomized,received 2 doses of lyophilized SDV,with Dose 2 received within 19 to 42 days after Dose 1,received Dose 3 of frozen liquid MDV,had at least 1 valid immunogenicity result within 28 to 42 days after Dose 3,were negative for both SARS-CoV-2 tests at Day 1 and 1 month post-Dose 3 visits, and had no other important protocol deviations as determined by clinician.
GMFRs were defined as ratios of the geometric mean concentration of IgG from 1 month after Dose 3 to geometric mean concentration of IgG before Dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
BNT162b2 Lyophilized SDV: Part 1
n=88 Participants
Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.
|
BNT162b2 Frozen-Liquid MDV: Part 1
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
|---|---|---|---|---|
|
GMFRs in Full-length S-binding IgG Levels From Before Dose 3 to 1 Month After Dose 3
|
16.0 Fold rise
Interval 13.9 to 18.5
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 1 Month after Dose 2, before Dose 3, and 1 Month after Dose 3Population: Evaluable immunogenicity population:Participants eligible and randomized,received 2 doses of lyophilized SDV,with Dose 2 received within 19 to 42 days after Dose 1,received Dose 3 of frozen liquid MDV,had at least 1 valid immunogenicity result within 28 to 42 days after Dose 3,negative for both SARS-CoV-2 tests at Day 1,1 month post Dose 3 visits, had no other important protocol deviations determined by clinician. Here, n= participants evaluable for specific timepoint.
GMCs of full-length S-binding IgG levels were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Outcome measures
| Measure |
BNT162b2 Lyophilized SDV: Part 1
n=88 Participants
Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.
|
BNT162b2 Frozen-Liquid MDV: Part 1
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
|---|---|---|---|---|
|
GMCs of Full-Length S-Binding IgG Levels at Baseline, 1 Month After Dose 2, Before Dose 3, and 1 Month After Dose 3
Baseline
|
2.1 Unit per milliliter
Interval 1.6 to 2.7
|
—
|
—
|
—
|
|
GMCs of Full-Length S-Binding IgG Levels at Baseline, 1 Month After Dose 2, Before Dose 3, and 1 Month After Dose 3
1 Month after Dose 2
|
4612.2 Unit per milliliter
Interval 4065.7 to 5232.1
|
—
|
—
|
—
|
|
GMCs of Full-Length S-Binding IgG Levels at Baseline, 1 Month After Dose 2, Before Dose 3, and 1 Month After Dose 3
Before Dose 3
|
874.4 Unit per milliliter
Interval 735.6 to 1039.4
|
—
|
—
|
—
|
|
GMCs of Full-Length S-Binding IgG Levels at Baseline, 1 Month After Dose 2, Before Dose 3, and 1 Month After Dose 3
1 Month after Dose 3
|
14006.7 Unit per milliliter
Interval 11902.7 to 16482.7
|
—
|
—
|
—
|
Adverse Events
BNT162b2 Lyophilized SDV: Part 1
Serious events: 0 serious events
Other events: 262 other events
Deaths: 0 deaths
BNT162b2 Frozen-Liquid MDV: Part 1
Serious events: 0 serious events
Other events: 274 other events
Deaths: 0 deaths
BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
BNT162b2 Frozen-Liquid MDV: Dose 3
Serious events: 0 serious events
Other events: 87 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BNT162b2 Lyophilized SDV: Part 1
n=279 participants at risk
Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3.
|
BNT162b2 Frozen-Liquid MDV: Part 1
n=280 participants at risk
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2
n=35 participants at risk
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2
n=35 participants at risk
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
BNT162b2 Frozen-Liquid MDV: Dose 3
n=114 participants at risk
Participants who originally received 2 doses of lyophilized SDV formulation of BNT162b2 30 mcg in Part 1 of the study were administered with an additional dose of frozen liquid MDV of BNT162b2 30 mcg at least 3 months after Dose 2. Participants were followed up for safety for 1 month after third dose of vaccine.
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.36%
1/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.36%
1/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Eye disorders
Conjunctivitis allergic
|
0.36%
1/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Eye disorders
Eye pain
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.36%
1/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.36%
1/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.36%
1/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.36%
1/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
General disorders
Chest pain
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.36%
1/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
General disorders
Fatigue
|
0.36%
1/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
General disorders
Injection site erythema
|
0.36%
1/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
General disorders
Injection site pruritus
|
0.36%
1/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Immune system disorders
Seasonal allergy
|
0.36%
1/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Infections and infestations
Acute sinusitis
|
0.36%
1/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.36%
1/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Infections and infestations
Herpes simplex
|
0.36%
1/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.36%
1/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.36%
1/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.36%
1/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Infections and infestations
COVID-19
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.36%
1/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
2.9%
1/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.36%
1/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.36%
1/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Infections and infestations
Gingivitis
|
0.36%
1/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.36%
1/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Infections and infestations
Suspected COVID-19
|
0.36%
1/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.36%
1/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.88%
1/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.36%
1/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.36%
1/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.71%
2/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar inflammation
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.88%
1/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.36%
1/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.36%
1/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Nervous system disorders
Headache
|
0.72%
2/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.36%
1/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
2.9%
1/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.88%
1/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Nervous system disorders
Dizziness
|
0.36%
1/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.36%
1/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Nervous system disorders
Paraesthesia
|
0.36%
1/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Nervous system disorders
Syncope
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.36%
1/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.36%
1/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Psychiatric disorders
Depression
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.36%
1/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.36%
1/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.36%
1/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.36%
1/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.36%
1/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
2.9%
1/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
General disorders
Influenza like illness
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
2.9%
1/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
General disorders
Injection site pain
|
0.36%
1/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
2.9%
1/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.88%
1/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Infections and infestations
Cystitis
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
2.9%
1/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
2.9%
1/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
2.9%
1/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
2.9%
1/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.88%
1/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
General disorders
Chills
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
1.8%
2/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
General disorders
Pyrexia
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.88%
1/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
1.8%
2/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Infections and infestations
Bacterial vulvovaginitis
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.88%
1/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.88%
1/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.88%
1/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.88%
1/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.88%
1/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.88%
1/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Gastrointestinal disorders
Diarrhoea (DIARRHEA)
|
22.9%
64/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
25.4%
71/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
14.3%
5/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
20.0%
7/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
12.3%
14/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Gastrointestinal disorders
Vomiting (VOMITING)
|
5.7%
16/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
4.3%
12/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
8.6%
3/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
2.9%
1/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
2.6%
3/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
General disorders
Chills (CHILLS)
|
30.1%
84/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
52.9%
148/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
25.7%
9/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
25.7%
9/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
36.8%
42/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
General disorders
Fatigue (FATIGUE)
|
71.3%
199/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
83.2%
233/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
68.6%
24/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
68.6%
24/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
59.6%
68/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
General disorders
Injection site erythema (REDNESS)
|
7.2%
20/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
8.6%
24/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
2.9%
1/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
6.1%
7/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
General disorders
Injection site pain (PAIN)
|
86.0%
240/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
93.2%
261/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
88.6%
31/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
80.0%
28/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
65.8%
75/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
General disorders
Injection site swelling (SWELLING)
|
6.1%
17/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
6.4%
18/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
0.00%
0/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
11.4%
4/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
6.1%
7/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
General disorders
Pyrexia (FEVER)
|
6.1%
17/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
14.6%
41/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
2.9%
1/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
5.7%
2/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
7.9%
9/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
21.9%
61/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
36.8%
103/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
22.9%
8/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
37.1%
13/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
15.8%
18/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
41.6%
116/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
54.6%
153/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
25.7%
9/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
45.7%
16/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
27.2%
31/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
|
Nervous system disorders
Headache (HEADACHE)
|
58.1%
162/279 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
70.7%
198/280 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
51.4%
18/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
54.3%
19/35 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
49.1%
56/114 • AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and 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.
|
Additional Information
BioNTech clinical trials patient information
BioNTech SE
Phone: +49 6131 9084
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee BioNTech SE 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