Trial Outcomes & Findings for Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines (NCT NCT04529538)
NCT ID: NCT04529538
Last Updated: 2024-11-20
Results Overview
A serious adverse event is any adverse event that resulted in any of the following outcomes: * Death * Was life-threatening * Required inpatient hospitalization or prolongation of existing hospitalization * Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * Congenital anomaly or birth defect * Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant and/or require medical or surgical intervention to prevent one of the outcomes listed above
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
226 participants
Primary outcome timeframe
From Day 1 to end of study, up to 169 days
Results posted on
2024-11-20
Participant Flow
Healthy volunteers were enrolled at four study sites in the United States. This study consisted of 4 cohorts, each with 2 groups of participants. Participants must have received either prior vaccination with at least 3 doses of inactivated poliovirus vaccine (IPV) with no history of receipt of oral poliomyelitis vaccine (OPV) (Cohorts 1 and 3) or previously received a primary polio immunization series containing OPV (Cohorts 2 and 4).
Cohorts 1 and 2 received vaccine against poliovirus type 1 and Cohorts 3 and 4 received vaccine against poliovirus type 3. In Cohorts 1 and 3 participants with an exclusive IPV vaccination history were randomized in a 1:1 ratio to receive novel oral poliomyelitis vaccine (nOPV) or Sabin strain monovalent oral poliomyelitis vaccine (mOPV) control. In Cohorts 2 and 4, participants with an OPV-containing vaccination history were randomized in a 2:1 ratio to receive nOPV or mOPV.
Participant milestones
| Measure |
Group1: nOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of novel oral polio vaccine type 1 (nOPV1) containing 10\^6.5 cell culture infectious dose 50% (CCID50) on Day 1.
|
Group 2: mOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin monovalent oral polio vaccine type 1 (mOPV1) containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of novel oral poliomyelitis vaccine type 3 (nOPV3) containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin monovalent oral polio vaccine type 3 (mOPV3) containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
23
|
53
|
27
|
20
|
21
|
40
|
21
|
|
Overall Study
Received 1st Vaccination
|
20
|
20
|
50
|
25
|
19
|
17
|
35
|
19
|
|
Overall Study
Received 2nd Vaccination
|
0
|
0
|
49
|
22
|
0
|
0
|
35
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
49
|
22
|
19
|
17
|
35
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
4
|
5
|
1
|
4
|
5
|
2
|
Reasons for withdrawal
| Measure |
Group1: nOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of novel oral polio vaccine type 1 (nOPV1) containing 10\^6.5 cell culture infectious dose 50% (CCID50) on Day 1.
|
Group 2: mOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin monovalent oral polio vaccine type 1 (mOPV1) containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of novel oral poliomyelitis vaccine type 3 (nOPV3) containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin monovalent oral polio vaccine type 3 (mOPV3) containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
1
|
0
|
1
|
1
|
2
|
0
|
|
Overall Study
Not eligible at enrollment
|
0
|
1
|
2
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
2
|
0
|
2
|
3
|
0
|
|
Overall Study
Other
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Deviation
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines
Baseline characteristics by cohort
| Measure |
Group1: nOPV1 (IPV History)
n=18 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=18 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
n=50 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
n=25 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
n=19 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
n=15 Participants
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
n=35 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
n=19 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
20.8 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
20.0 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
30.0 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
30.0 years
STANDARD_DEVIATION 6.5 • n=4 Participants
|
20.7 years
STANDARD_DEVIATION 2.1 • n=21 Participants
|
21.5 years
STANDARD_DEVIATION 2.4 • n=8 Participants
|
30.4 years
STANDARD_DEVIATION 6.6 • n=8 Participants
|
33.1 years
STANDARD_DEVIATION 8.8 • n=24 Participants
|
27.1 years
STANDARD_DEVIATION 5.7 • n=42 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
110 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
89 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
186 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
38 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
136 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to end of study, up to 169 daysPopulation: The Reactogenicity Population was defined as all participants who provided informed consent and received a study vaccine.
A serious adverse event is any adverse event that resulted in any of the following outcomes: * Death * Was life-threatening * Required inpatient hospitalization or prolongation of existing hospitalization * Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * Congenital anomaly or birth defect * Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant and/or require medical or surgical intervention to prevent one of the outcomes listed above
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=20 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=20 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
n=50 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
n=25 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
n=19 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
n=17 Participants
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
n=35 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
n=19 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From vaccination to 7 days post vaccination (Days 1-7)Population: The Reactogenicity Population was defined as all participants who provided informed consent and received a study vaccine.
Solicited AEs are pre-specified AEs that are common or known to be associated with vaccination that are actively monitored as potential indicators of vaccine reactogenicity. Solicited AEs for this study included: * Fever (oral temperature ≥ 38.0°C or 100.4°F) * Chills * Fatigue * Headache * Muscle aches/myalgias * Joint aches/arthralgias * Nausea * Vomiting * Abdominal pain * Diarrhea
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=20 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=20 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
n=50 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
n=25 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
n=19 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
n=17 Participants
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
n=35 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
n=19 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Adverse Events (AEs) 7 Days After First Dose of Study Vaccine
Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) 7 Days After First Dose of Study Vaccine
Chills
|
1 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) 7 Days After First Dose of Study Vaccine
Any Solicited Event
|
11 Participants
|
12 Participants
|
25 Participants
|
15 Participants
|
10 Participants
|
9 Participants
|
13 Participants
|
7 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) 7 Days After First Dose of Study Vaccine
Fatigue
|
5 Participants
|
8 Participants
|
17 Participants
|
9 Participants
|
7 Participants
|
7 Participants
|
9 Participants
|
5 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) 7 Days After First Dose of Study Vaccine
Headache
|
5 Participants
|
7 Participants
|
10 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) 7 Days After First Dose of Study Vaccine
Muscle Aches/Myalgias
|
2 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) 7 Days After First Dose of Study Vaccine
Joint Aches/Arthralgias
|
1 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) 7 Days After First Dose of Study Vaccine
Nausea
|
2 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) 7 Days After First Dose of Study Vaccine
Vomiting
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) 7 Days After First Dose of Study Vaccine
Abdominal pain
|
5 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) 7 Days After First Dose of Study Vaccine
Diarrhea
|
2 Participants
|
4 Participants
|
9 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From Day 29 to Day 35Population: The Reactogenicity Population was defined as all participants who provided informed consent and received a study vaccine. The analysis includes groups / participants who received a 2nd vaccination.
Solicited AEs are pre-specified AEs that are common or known to be associated with vaccination that are actively monitored as potential indicators of vaccine reactogenicity. Solicited AEs for this study included: * Fever (oral temperature ≥ 38.0°C or 100.4°F) * Chills * Fatigue * Headache * Muscle aches/myalgias * Joint aches/arthralgias * Nausea * Vomiting * Abdominal pain * Diarrhea
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
n=49 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
n=22 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
n=35 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
n=18 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Adverse Events 7 Days After Second Dose of Study Vaccine
Any Solicited Event
|
—
|
—
|
16 Participants
|
12 Participants
|
—
|
—
|
6 Participants
|
7 Participants
|
|
Number of Participants With Solicited Adverse Events 7 Days After Second Dose of Study Vaccine
Fever
|
—
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events 7 Days After Second Dose of Study Vaccine
Chills
|
—
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events 7 Days After Second Dose of Study Vaccine
Fatigue
|
—
|
—
|
8 Participants
|
6 Participants
|
—
|
—
|
1 Participants
|
3 Participants
|
|
Number of Participants With Solicited Adverse Events 7 Days After Second Dose of Study Vaccine
Headache
|
—
|
—
|
9 Participants
|
5 Participants
|
—
|
—
|
3 Participants
|
2 Participants
|
|
Number of Participants With Solicited Adverse Events 7 Days After Second Dose of Study Vaccine
Muscle Aches/Myalgias
|
—
|
—
|
4 Participants
|
3 Participants
|
—
|
—
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events 7 Days After Second Dose of Study Vaccine
Joint Aches/Arthralgias
|
—
|
—
|
1 Participants
|
4 Participants
|
—
|
—
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events 7 Days After Second Dose of Study Vaccine
Nausea
|
—
|
—
|
3 Participants
|
2 Participants
|
—
|
—
|
3 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events 7 Days After Second Dose of Study Vaccine
Vomiting
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events 7 Days After Second Dose of Study Vaccine
Abdominal pain
|
—
|
—
|
4 Participants
|
2 Participants
|
—
|
—
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events 7 Days After Second Dose of Study Vaccine
Diarrhea
|
—
|
—
|
4 Participants
|
4 Participants
|
—
|
—
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From vaccination to 28 days post vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination)Population: Reactogenicity population; the analysis includes participants who received each vaccination
Unsolicited AEs are any AEs reported spontaneously by the participant, observed by the study personnel during study visits or those identified during review of medical records or source documents. In the absence of a diagnosis, abnormal physical examination findings or abnormal clinical safety laboratory test results that are assessed by the investigator to be clinically significant were reported as an AE.
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=20 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=20 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
n=50 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
n=25 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
n=19 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
n=17 Participants
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
n=35 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
n=19 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events (AEs) up to 28 Days Post Vaccination
After 1st dose
|
7 Participants
|
7 Participants
|
21 Participants
|
10 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) up to 28 Days Post Vaccination
After 2nd dose
|
—
|
—
|
16 Participants
|
7 Participants
|
—
|
—
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 29 (28 days post-vaccination)Population: The Per-Protocol Population (PPP) for immunogenicity was defined as all participants in the Reactogenicity Population who provided a baseline and at least 1 post-vaccination evaluable serum sample and who received correct study vaccinations per randomization with no major protocol deviations that might interfere with the immunogenicity result. The PPP was determined separately for each time point. The analysis includes groups with prior IPV history who received vaccination with a type 1 OPV.
Blood samples collected from participants for type-specific poliovirus neutralizing antibodies were analyzed at the Polio and Picornavirus Laboratory Branch at the United States Centers for Disease Control and Prevention (CDC). For all immunogenicity endpoints, data are presented separately by: * Prior vaccination history (exclusively IPV vs OPV), and * Type-specific poliovirus vaccine received (type 1 vs type 3).
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=18 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=15 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Median Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
Baseline
|
5.67 log₂ titer
Interval 5.34 to 7.33
|
6.00 log₂ titer
Interval 5.83 to 7.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Median Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
Day 29
|
NA log₂ titer
Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
|
NA log₂ titer
Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 29 (28 days post-vaccination) and Day 57 (28 days after 2nd vaccination)Population: The Per-Protocol Population (PPP) for immunogenicity was defined as all participants in the Reactogenicity Population who provided a baseline and at least 1 post-vaccination evaluable serum sample and who received correct study vaccinations per randomization with no major protocol deviations that might interfere with the immunogenicity result. The PPP was determined separately for each time point. The analysis includes groups with prior OPV history who received vaccination with a type 1 OPV.
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=48 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=23 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Median Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Day 57
|
NA log₂ titer
Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
|
NA log₂ titer
Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Median Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Baseline
|
6.83 log₂ titer
Interval 6.17 to 7.83
|
7.17 log₂ titer
Interval 5.5 to 8.17
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Median Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Day 29
|
NA log₂ titer
Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
|
NA log₂ titer
Interval 10.17 to
Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 29 (28 days post-vaccination)Population: The Per-Protocol Population (PPP) for immunogenicity was defined as all participants in the Reactogenicity Population who provided a baseline and at least 1 post-vaccination evaluable serum sample and who received correct study vaccinations per randomization with no major protocol deviations that might interfere with the immunogenicity result. The PPP was determined separately for each time point. The analysis includes groups with prior IPV history who received vaccination with a type 3 OPV.
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=19 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=15 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Median Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
Baseline
|
6.17 log₂ titer
Interval 5.83 to 8.17
|
6.17 log₂ titer
Interval 5.5 to 6.83
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Median Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
Day 29
|
NA log₂ titer
Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
|
NA log₂ titer
Interval 9.5 to
Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 29 (28 days after the 1st vaccination) and Day 57 (28 days after 2nd vaccination)Population: The Per-Protocol Population (PPP) for immunogenicity was defined as all participants in the Reactogenicity Population who provided a baseline and at least 1 post-vaccination evaluable serum sample and who received correct study vaccinations per randomization with no major protocol deviations that might interfere with the immunogenicity result. The PPP was determined separately for each time point. The analysis includes groups with prior OPV history who received vaccination with a type 3 OPV.
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=35 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=19 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Median Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Baseline
|
5.83 log₂ titer
Interval 4.17 to 6.83
|
6.50 log₂ titer
Interval 5.17 to 8.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Median Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Day 29
|
NA log₂ titer
Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
|
NA log₂ titer
Interval 9.5 to
Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Median Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Day 57
|
NA log₂ titer
Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
|
9.83 log₂ titer
Interval 9.17 to
Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 29 (28 days post-vaccination)Population: The Per-Protocol Population (PPP) for immunogenicity was defined as all participants in the Reactogenicity Population who provided a baseline and at least 1 post-vaccination evaluable serum sample and who received correct study vaccinations per randomization with no major protocol deviations that might interfere with the immunogenicity result. The PPP was determined separately for each time point. The analysis includes groups with prior IPV history who received vaccination with a type 1 OPV.
GMT and 95% confidence intervals are maximum likelihood estimates incorporating left and right censoring at the lower limit of quantitation (LLOQ) and ULOQ, respectively.
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=18 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=15 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Anti-poliovirus Type 1 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
Baseline
|
49.6 titer
Interval 26.7 to 92.1
|
73.2 titer
Interval 33.6 to 159.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Anti-poliovirus Type 1 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
Day 29
|
5208.2 titer
Interval 904.6 to 29986.4
|
2846.7 titer
Interval 716.6 to 11307.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 29 (28 days after 1st vaccination) and Day 57 (28 days after 2nd vaccination)Population: The Per-Protocol Population (PPP) for immunogenicity was defined as all participants in the Reactogenicity Population who provided a baseline and at least 1 post-vaccination evaluable serum sample and who received correct study vaccinations per randomization with no major protocol deviations that might interfere with the immunogenicity result. The PPP was determined separately for each time point. The analysis includes groups with prior OPV history who received vaccination with a type 1 OPV.
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=48 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=23 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer of Anti-poliovirus Type 1 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Day 57
|
4407.5 titer
Interval 1547.8 to 12551.0
|
16500.8 titer
Interval 808.4 to 336813.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer of Anti-poliovirus Type 1 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Baseline
|
111.6 titer
Interval 70.5 to 176.5
|
116.0 titer
Interval 48.1 to 280.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer of Anti-poliovirus Type 1 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Day 29
|
10869.2 titer
Interval 1953.5 to 60474.3
|
4495.1 titer
Interval 960.9 to 21027.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 29 (28 days post-vaccination)Population: The Per-Protocol Population (PPP) for immunogenicity was defined as all participants in the Reactogenicity Population who provided a baseline and at least 1 post-vaccination evaluable serum sample and who received correct study vaccinations per randomization with no major protocol deviations that might interfere with the immunogenicity result. The PPP was determined separately for each time point. The analysis includes groups with prior IPV history who received vaccination with a type 3 OPV.
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=19 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=15 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer of Anti-poliovirus Type 3 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
Baseline
|
113.0 titer
Interval 56.7 to 225.2
|
74.6 titer
Interval 43.2 to 128.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer of Anti-poliovirus Type 3 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
Day 29
|
3091.2 titer
Interval 1095.6 to 8721.9
|
3945.5 titer
Interval 736.6 to 21132.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 29 (28 days after 1st vaccination) and Day 57 (28 days after 2nd vaccination)Population: The Per-Protocol Population (PPP) for immunogenicity was defined as all participants in the Reactogenicity Population who provided a baseline and at least 1 post-vaccination evaluable serum sample and who received correct study vaccinations per randomization with no major protocol deviations that might interfere with the immunogenicity result. The PPP was determined separately for each time point. The analysis includes groups with prior OPV history who received vaccination with a type 3 OPV.
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=35 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=19 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer of Anti-poliovirus Type 3 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Baseline
|
53.4 titer
Interval 29.1 to 97.8
|
101.1 titer
Interval 47.7 to 214.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer of Anti-poliovirus Type 3 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Day 29
|
2810.1 titer
Interval 1364.0 to 5789.3
|
1483.8 titer
Interval 758.8 to 2901.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer of Anti-poliovirus Type 3 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Day 57
|
3337.0 titer
Interval 1293.1 to 8611.7
|
1076.8 titer
Interval 613.5 to 1890.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (pre-vaccination) and Day 29 (28 days post-vaccination)Population: Per Protocol Population. The analysis includes groups with prior IPV history who received vaccination with a type 1 OPV; participants were only included in each analysis if the appropriate measure could be observed based on Baseline neutralizing antibody titer.
* Seroconversion (SCR) is defined as a minimum 4-fold increase in titer from Baseline (pre-vaccination) to 28 days post-vaccination among those participants with a 4-fold increase possible to observe, i.e., with a Baseline titer not greater than 8.5 log₂. * Minimum 2-fold-rise from Baseline to 28 days post-vaccination among those participants with a 2-fold increase possible to observe, i.e., with a Baseline titer not greater than 9.5 log₂. * Any fold-rise is defined as any increase in titer from Baseline to 28 days post-vaccination (log₂ neutralizing antibody titer post-dose minus Baseline \> 0), among those with an increase possible to observe, i.e., with a Baseline titer less than 10.5 log₂.
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=18 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=14 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Vaccination Among Participants With a Vaccine History of IPV
≥ 4-fold rise
|
88.9 percentage of participants
Interval 65.29 to 98.62
|
92.9 percentage of participants
Interval 66.13 to 99.82
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Vaccination Among Participants With a Vaccine History of IPV
≥ 2-fold rise
|
94.4 percentage of participants
Interval 72.71 to 99.86
|
100 percentage of participants
Interval 76.84 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Vaccination Among Participants With a Vaccine History of IPV
Any fold-rise
|
100 percentage of participants
Interval 81.47 to 100.0
|
100 percentage of participants
Interval 76.84 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 29 (28 days post-vaccination) and Day 57 (28 days after 2nd vaccination)Population: Per Protocol Population; The analysis includes groups with prior OPV history who received vaccination with a type 1 OPV; participants were only included in each analysis if the appropriate measure could be observed based on Baseline neutralizing antibody titer.
* Seroconversion (SCR) is defined as a minimum 4-fold increase in titer from Baseline (pre-vaccination) to 28 days post-vaccination among those participants with a 4-fold increase possible to observe, i.e., with a Baseline titer not greater than 8.5 log₂. * Minimum 2-fold-rise from Baseline to 28 days post-vaccination among those participants with a 2-fold increase possible to observe, i.e., with a Baseline titer not greater than 9.5 log₂. * Any fold-rise is defined as any increase in titer from Baseline to 28 days post-vaccination (log₂ neutralizing antibody titer post-dose minus Baseline \> 0), among those with an increase possible to observe, i.e., with a Baseline titer less than 10.5 log₂.
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=47 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=20 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Each Vaccination Among Participants With a Vaccine History of OPV
Day 29: ≥ 2-fold rise
|
83.3 percentage of participants
Interval 68.64 to 93.03
|
90.0 percentage of participants
Interval 68.3 to 98.77
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Each Vaccination Among Participants With a Vaccine History of OPV
Day 29: ≥ 4-fold rise
|
86.1 percentage of participants
Interval 70.5 to 95.33
|
88.9 percentage of participants
Interval 65.29 to 98.62
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Each Vaccination Among Participants With a Vaccine History of OPV
Day 29: Any fold-rise
|
83.0 percentage of participants
Interval 69.19 to 92.35
|
100 percentage of participants
Interval 83.16 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Each Vaccination Among Participants With a Vaccine History of OPV
Day 57: ≥ 4-fold rise
|
97.1 percentage of participants
Interval 85.08 to 99.93
|
88.9 percentage of participants
Interval 65.29 to 98.62
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Each Vaccination Among Participants With a Vaccine History of OPV
Day 57: ≥ 2-fold rise
|
95.1 percentage of participants
Interval 83.47 to 99.4
|
94.7 percentage of participants
Interval 73.97 to 99.87
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Each Vaccination Among Participants With a Vaccine History of OPV
Day 57: Any fold-rise
|
97.8 percentage of participants
Interval 88.47 to 99.94
|
94.7 percentage of participants
Interval 73.97 to 99.87
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 29 (28 days post-vaccination)Population: Per Protocol Population. The analysis includes groups with prior IPV history who received vaccination with a type 3 OPV; participants were only included in each analysis if the appropriate measure could be observed based on Baseline neutralizing antibody titer.
* Seroconversion (SCR) is defined as a minimum 4-fold increase in titer from Baseline (pre-vaccination) to 28 days post-vaccination among those participants with a 4-fold increase possible to observe, i.e., with a Baseline titer not greater than 8.5 log₂. * Minimum 2-fold-rise from Baseline to 28 days post-vaccination among those participants with a 2-fold increase possible to observe, i.e., with a Baseline titer not greater than 9.5 log₂. * Any fold-rise is defined as any increase in titer from Baseline to 28 days post-vaccination (log₂ neutralizing antibody titer post-dose minus Baseline \> 0), among those with an increase possible to observe, i.e., with a Baseline titer less than 10.5 log₂.
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=18 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=15 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Vaccination Among Participants With a Vaccine History of IPV
≥ 4-fold rise
|
100 percentage of participants
Interval 78.2 to 100.0
|
85.7 percentage of participants
Interval 57.9 to 98.22
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Vaccination Among Participants With a Vaccine History of IPV
≥ 2-fold rise
|
94.1 percentage of participants
Interval 71.31 to 99.85
|
100 percentage of participants
Interval 78.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Vaccination Among Participants With a Vaccine History of IPV
Any fold-rise
|
94.4 percentage of participants
Interval 72.71 to 99.86
|
100 percentage of participants
Interval 78.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 29 (28 days after 1st vaccination) and Day 57 (28 days after 2nd vaccination)Population: Per Protocol Population; The analysis includes groups with prior OPV history who received vaccination with a type 3 OPV; participants were only included in each analysis if the appropriate measure could be observed based on Baseline neutralizing antibody titer.
* Seroconversion (SCR) is defined as a minimum 4-fold increase in titer from Baseline (pre-vaccination) to 28 days post-vaccination among those participants with a 4-fold increase possible to observe, i.e., with a Baseline titer not greater than 8.5 log₂. * Minimum 2-fold-rise from Baseline to 28 days post-vaccination among those participants with a 2-fold increase possible to observe, i.e., with a Baseline titer not greater than 9.5 log₂. * Any fold-rise is defined as any increase in titer from Baseline to 28 days post-vaccination (log₂ neutralizing antibody titer post-dose minus Baseline \> 0), among those with an increase possible to observe, i.e., with a Baseline titer less than 10.5 log₂.
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=34 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=18 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Each Vaccination Among Participants With a Vaccine History of OPV
Day 29: ≥ 4-fold rise
|
96.4 percentage of participants
Interval 81.65 to 99.91
|
86.7 percentage of participants
Interval 59.54 to 98.34
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Each Vaccination Among Participants With a Vaccine History of OPV
Day 29: ≥ 2-fold rise
|
96.9 percentage of participants
Interval 83.78 to 99.92
|
83.3 percentage of participants
Interval 58.58 to 96.42
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Each Vaccination Among Participants With a Vaccine History of OPV
Day 29: Any fold-rise
|
94.1 percentage of participants
Interval 80.32 to 99.28
|
94.4 percentage of participants
Interval 72.71 to 99.86
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Each Vaccination Among Participants With a Vaccine History of OPV
Day 57: ≥ 4-fold rise
|
96.4 percentage of participants
Interval 81.65 to 99.91
|
78.6 percentage of participants
Interval 49.2 to 95.34
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Each Vaccination Among Participants With a Vaccine History of OPV
Day 57: ≥ 2-fold rise
|
90.6 percentage of participants
Interval 74.98 to 98.02
|
76.5 percentage of participants
Interval 50.1 to 93.19
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Each Vaccination Among Participants With a Vaccine History of OPV
Day 57: Any fold-rise
|
100 percentage of participants
Interval 89.72 to 100.0
|
88.2 percentage of participants
Interval 63.56 to 98.54
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 57Population: Participants in the Safety Population with available PCR data; the analysis includes groups with prior IPV history.
The presence of the vaccine virus in stool samples was assessed using polymerase chain reaction (PCR). Time to cessation of shedding is defined as the time between vaccination and the last PCR-positive stool prior to 2 consecutive PCR-negative stools (with a minimum 24-hour interval between the 2 negative stools). The time to cessation of fecal shedding of nOPV1 and nOPV3 in prior IPV recipients was estimated using Kaplan-Meier methodology with interval-censoring.
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=18 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=18 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
n=19 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
n=15 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Cessation of Fecal Shedding of Vaccine Virus in Participants With IPV Vaccination History
|
22 days
Interval 15.0 to 24.0
|
20 days
Interval 20.0 to 29.0
|
20 days
Interval 15.0 to 37.0
|
29 days
Interval 22.0 to 42.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From vaccination through 28 days after each vaccinationPopulation: Participants in the Safety Population with available PCR data at each time point; the analysis includes groups with prior OPV history.
The presence of the vaccine virus in stool samples was assessed using polymerase chain reaction (PCR). Time to cessation of shedding is defined as the time between vaccination and the last PCR-positive stool prior to 2 consecutive PCR-negative stools (with a minimum 24-hour interval between the 2 negative stools). The time to cessation of fecal shedding of nOPV1 and nOPV3 in prior OPV recipients was evaluated separately after each dose, estimated using Kaplan-Meier methodology with interval-censoring.
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=50 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=25 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
n=35 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
n=19 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Cessation of Fecal Shedding of Vaccine Virus in Participants With OPV Vaccination History
After 2nd dose
|
5 days
Could not be calculated due to low numbers of participants with positive shedding results
|
7 days
Interval 4.0 to 7.0
|
2 days
Could not be calculated due to low numbers of participants with positive shedding results
|
2 days
Could not be calculated due to low numbers of participants with positive shedding results
|
—
|
—
|
—
|
—
|
|
Time to Cessation of Fecal Shedding of Vaccine Virus in Participants With OPV Vaccination History
After first dose
|
20 days
Interval 9.0 to 20.0
|
20 days
Interval 14.0 to 20.0
|
21 days
Interval 13.0 to
Could not be calculated due to low numbers of participants with positive shedding results
|
17 days
Interval 8.0 to
Could not be calculated due to low numbers of participants with positive shedding results
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57Population: Participants in the Safety Population with available PCR data at each time point. The analysis includes groups with prior IPV history who received vaccination with a type 1 OPV.
Presence of the vaccine virus in stool samples was assessed by polymerase chain reaction (PCR). This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=18 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=18 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Shedding Type 1 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Day 3
|
62.5 percentage of participants
Interval 35.4 to 84.8
|
82.4 percentage of participants
Interval 56.6 to 96.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Shedding Type 1 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Day 5
|
93.3 percentage of participants
Interval 68.1 to 99.8
|
100 percentage of participants
Interval 75.3 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Shedding Type 1 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Day 8
|
100 percentage of participants
Interval 80.5 to 100.0
|
100 percentage of participants
Interval 81.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Shedding Type 1 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Day 10
|
100 percentage of participants
Interval 80.5 to 100.0
|
100 percentage of participants
Interval 79.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Shedding Type 1 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Day 15
|
94.1 percentage of participants
Interval 71.3 to 99.9
|
81.3 percentage of participants
Interval 54.4 to 96.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Shedding Type 1 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Day 22
|
50.0 percentage of participants
Interval 26.0 to 74.0
|
43.8 percentage of participants
Interval 19.8 to 70.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Shedding Type 1 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Day 29
|
22.2 percentage of participants
Interval 6.4 to 47.6
|
26.7 percentage of participants
Interval 7.8 to 55.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Shedding Type 1 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Day 36
|
30.8 percentage of participants
Interval 9.1 to 61.4
|
13.3 percentage of participants
Interval 1.7 to 40.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Shedding Type 1 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Day 43
|
0.0 percentage of participants
Interval 0.0 to 21.8
|
6.7 percentage of participants
Interval 0.2 to 31.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Shedding Type 1 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Day 50
|
0.0 percentage of participants
Interval 0.0 to 18.5
|
0.0 percentage of participants
Interval 0.0 to 23.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Shedding Type 1 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Day 57
|
0.0 percentage of participants
Interval 0.0 to 20.6
|
0.0 percentage of participants
Interval 0.0 to 23.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Shedding Type 1 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
At any time point
|
100 percentage of participants
Interval 81.5 to 100.0
|
100 percentage of participants
Interval 81.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57Population: Participants in the Safety Population with available PCR data at each time point. The analysis includes groups with prior IPV history who received vaccination with a type 3 OPV
Presence of the vaccine virus in stool samples was assessed by polymerase chain reaction (PCR). This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=19 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=15 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Shedding Type 3 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Day 3
|
88.2 percentage of participants
Interval 63.6 to 98.5
|
71.4 percentage of participants
Interval 41.9 to 91.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Shedding Type 3 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Day 5
|
100 percentage of participants
Interval 80.5 to 100.0
|
100 percentage of participants
Interval 73.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Shedding Type 3 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Day 8
|
100 percentage of participants
Interval 80.5 to 100.0
|
100 percentage of participants
Interval 76.8 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Shedding Type 3 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Day 10
|
93.8 percentage of participants
Interval 69.8 to 99.8
|
100 percentage of participants
Interval 75.3 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Shedding Type 3 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Day 15
|
76.5 percentage of participants
Interval 50.1 to 93.2
|
93.3 percentage of participants
Interval 68.1 to 99.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Shedding Type 3 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Day 22
|
38.9 percentage of participants
Interval 17.3 to 64.3
|
61.5 percentage of participants
Interval 31.6 to 86.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Shedding Type 3 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Day 29
|
38.9 percentage of participants
Interval 17.3 to 64.3
|
50.0 percentage of participants
Interval 23.0 to 77.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Shedding Type 3 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Day 36
|
27.8 percentage of participants
Interval 9.7 to 53.5
|
33.3 percentage of participants
Interval 9.9 to 65.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Shedding Type 3 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Day 43
|
11.8 percentage of participants
Interval 1.5 to 36.4
|
7.1 percentage of participants
Interval 0.2 to 33.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Shedding Type 3 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Day 50
|
0.0 percentage of participants
Interval 0.0 to 19.5
|
7.1 percentage of participants
Interval 0.2 to 33.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Shedding Type 3 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Day 57
|
0.0 percentage of participants
Interval 0.0 to 19.5
|
6.7 percentage of participants
Interval 0.2 to 31.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Shedding Type 3 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
At any time point
|
100 percentage of participants
Interval 82.4 to 100.0
|
100 percentage of participants
Interval 78.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57Population: Participants in the Safety population who were PCR-positive for poliovirus type 1 viral shedding and with available CCID50 data. The analysis includes groups with prior IPV history who received vaccination with a type 1 OPV.
Samples positive for vaccine virus in stool as detected by PCR were quantified using a cell culture infectious dose assay. Participants who were PCR-positive for type 1 viral shedding but with log₁₀ CCID50 per gram ≤ LLOQ contributed a value equal to the LLOQ. This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=18 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=18 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Amount of Type 1 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Day 3
|
2.94 log₁₀ CCID50 per gram
Interval 2.75 to 3.875
|
3.22 log₁₀ CCID50 per gram
Interval 2.75 to 4.211
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Type 1 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Day 5
|
3.22 log₁₀ CCID50 per gram
Interval 2.922 to 4.125
|
4.28 log₁₀ CCID50 per gram
Interval 3.906 to 4.875
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Type 1 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Day 8
|
3.41 log₁₀ CCID50 per gram
Interval 2.813 to 4.0
|
4.33 log₁₀ CCID50 per gram
Interval 4.109 to 4.609
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Type 1 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Day 10
|
3.19 log₁₀ CCID50 per gram
Interval 2.938 to 3.719
|
4.08 log₁₀ CCID50 per gram
Interval 3.063 to 4.531
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Type 1 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Day 15
|
2.75 log₁₀ CCID50 per gram
Interval 2.75 to 2.813
|
2.75 log₁₀ CCID50 per gram
Interval 2.75 to 2.781
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Type 1 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Day 22
|
2.75 log₁₀ CCID50 per gram
Interval 2.75 to 3.219
|
2.75 log₁₀ CCID50 per gram
Interval 2.75 to 3.313
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Type 1 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Day 29
|
2.77 log₁₀ CCID50 per gram
Interval 2.75 to 2.781
|
2.88 log₁₀ CCID50 per gram
Interval 2.75 to 3.625
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Type 1 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Day 36
|
2.75 log₁₀ CCID50 per gram
Interval 2.75 to 3.313
|
2.91 log₁₀ CCID50 per gram
Interval 2.75 to 3.063
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Type 1 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Day 43
|
—
|
3.34 log₁₀ CCID50 per gram
Interval 3.34 to 3.34
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57Population: Participants in the Safety population who were PCR-positive for poliovirus type 3 viral shedding. The analysis includes groups with prior IPV history who received vaccination with a type 3 OPV.
Samples positive for vaccine virus in stool as detected by PCR were quantified using a cell culture infectious dose assay. Participants who were PCR-positive for type 3 viral shedding but with log₁₀ CCID50 per gram ≤ LLOQ contributed a value equal to the LLOQ. This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=19 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=15 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Amount of Type 3 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Day 3
|
4.06 log₁₀ CCID50 per gram
Interval 2.938 to 4.75
|
4.00 log₁₀ CCID50 per gram
Interval 2.781 to 4.734
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Type 3 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Day 5
|
3.88 log₁₀ CCID50 per gram
Interval 2.906 to 4.5
|
4.23 log₁₀ CCID50 per gram
Interval 3.063 to 4.672
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Type 3 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Day 8
|
4.28 log₁₀ CCID50 per gram
Interval 3.094 to 4.594
|
4.42 log₁₀ CCID50 per gram
Interval 3.094 to 4.875
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Type 3 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Day 10
|
4.16 log₁₀ CCID50 per gram
Interval 2.844 to 4.375
|
3.97 log₁₀ CCID50 per gram
Interval 3.0 to 4.938
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Type 3 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Day 15
|
2.84 log₁₀ CCID50 per gram
Interval 2.75 to 3.063
|
3.02 log₁₀ CCID50 per gram
Interval 2.766 to 3.469
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Type 3 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Day 22
|
2.75 log₁₀ CCID50 per gram
Interval 2.75 to 2.781
|
3.09 log₁₀ CCID50 per gram
Interval 2.875 to 4.125
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Type 3 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Day 29
|
2.75 log₁₀ CCID50 per gram
Interval 2.75 to 2.813
|
2.78 log₁₀ CCID50 per gram
Interval 2.75 to 2.844
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Type 3 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Day 36
|
2.78 log₁₀ CCID50 per gram
Interval 2.75 to 3.281
|
2.75 log₁₀ CCID50 per gram
Interval 2.75 to 3.844
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Type 3 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Day 43
|
2.77 log₁₀ CCID50 per gram
Interval 2.75 to 2.781
|
2.97 log₁₀ CCID50 per gram
Interval 2.97 to 2.97
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Type 3 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Day 50
|
—
|
2.81 log₁₀ CCID50 per gram
Interval 2.81 to 2.81
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Amount of Type 3 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Day 57
|
—
|
3.78 log₁₀ CCID50 per gram
Interval 3.78 to 3.78
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 8, 15, 22, and 29Population: Participants with complete data at all four time points (Days 8, 15, 22, and 29) were included in the analysis. The analysis includes groups with prior IPV history.
The Shedding Index Endpoint (SIE) was computed as the mean of the log₁₀ cell culture infectious dose 50% (CCID50) per gram from nominal collection days 7, 14, 21, and 28 post-dose (i.e., study days 8, 15, 22, and 29). Participants who were PCR-positive for type-specific viral shedding but with log₁₀ CCID50 per gram ≤ LLOQ contributed a value equal to the LLOQ. This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=16 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=13 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
n=14 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
n=11 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Shedding Index of Vaccine Virus Shedding in Stool in Participants With IPV Vaccination History
|
1.88 log₁₀ CCID50 per gram
Interval 1.477 to 2.344
|
1.96 log₁₀ CCID50 per gram
Interval 1.734 to 2.477
|
2.20 log₁₀ CCID50 per gram
Interval 1.844 to 3.016
|
2.41 log₁₀ CCID50 per gram
Interval 1.766 to 3.578
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 3, 5, 8, 10, 15, 22, and 29Population: Participants with available CCID50/g shedding data (must have data from Day 3 and Day 29, and no 2 missing consecutive samples from Days 5, 8, 10, 15, and 22). The analysis includes groups with prior IPV history.
Area under the curve (AUC) was computed for each participant using CCID50 per gram data collected through Day 29 using the linear trapezoidal rule. Participants were assumed to be not shedding at time of vaccination (i.e. there was no stool collection on Day 1). Participants who were PCR-positive for type-specific viral shedding but with log₁₀ CCID50 per gram ≤ LLOQ contributed a value equal to the LLOQ. This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Outcome measures
| Measure |
Group1: nOPV1 (IPV History)
n=15 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=15 Participants
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
n=17 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
n=12 Participants
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Vaccination to 28 Days After Vaccination (AUC₀-₂₈) of Vaccine Virus Shed in Stool in Participants With an IPV Vaccination History
|
57.84 days * log₁₀ CCID50/gram
Interval 10.188 to 66.625
|
66.88 days * log₁₀ CCID50/gram
Interval 52.797 to 78.344
|
60.80 days * log₁₀ CCID50/gram
Interval 49.172 to 80.438
|
71.46 days * log₁₀ CCID50/gram
Interval 56.711 to 87.945
|
—
|
—
|
—
|
—
|
Adverse Events
Group1: nOPV1 (IPV History)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Group 2: mOPV1 (IPV History)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Group 3: nOPV1 (OPV History)
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Group 4: mOPV1 (OPV History)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Group 5: nOPV3 (IPV History)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Group 6: mOPV3 (IPV History)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 7: nOPV3 (OPV History)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Group 8: mOPV3 (OPV History)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group1: nOPV1 (IPV History)
n=20 participants at risk
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10\^6.5 CCID50 on Day 1.
|
Group 2: mOPV1 (IPV History)
n=20 participants at risk
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10\^6.0 CCID50 on Day 1.
|
Group 3: nOPV1 (OPV History)
n=50 participants at risk
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 4: mOPV1 (OPV History)
n=25 participants at risk
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10\^6.0 CCID50/dose, given 28 days apart.
|
Group 5: nOPV3 (IPV History)
n=19 participants at risk
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10\^6.5 CCID50 on Day 1.
|
Group 6: mOPV3 (IPV History)
n=17 participants at risk
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10\^5.8 CCID50 on Day 1.
|
Group 7: nOPV3 (OPV History)
n=35 participants at risk
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10\^6.5 CCID50/dose, given 28 days apart.
|
Group 8: mOPV3 (OPV History)
n=19 participants at risk
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10\^5.8 CCID50/dose, given 28 days apart.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
25.0%
5/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
40.0%
8/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
42.0%
21/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
44.0%
11/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
36.8%
7/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
47.1%
8/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
25.7%
9/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
36.8%
7/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
General disorders
Chills
|
5.0%
1/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
25.0%
5/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
6.0%
3/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
12.0%
3/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.3%
1/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.9%
1/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.3%
1/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
General disorders
Pyrexia
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
4.0%
2/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.9%
1/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.3%
1/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.0%
3/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
20.0%
4/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
22.0%
11/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
40.0%
10/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
15.8%
3/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
41.2%
7/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
14.3%
5/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
26.3%
5/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
5/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
25.0%
5/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
14.0%
7/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
16.0%
4/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
31.6%
6/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.9%
1/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
14.3%
5/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
10.5%
2/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
10.0%
2/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
16.0%
8/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
12.0%
3/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.3%
1/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.9%
1/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
22.9%
8/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.3%
1/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
4.0%
2/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
4.0%
1/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.9%
1/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.3%
1/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
10.0%
2/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
8.0%
2/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.3%
1/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.9%
1/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
4.0%
1/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
5.0%
1/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.3%
1/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Gastrointestinal disorders
Odynophagia
|
5.0%
1/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Nervous system disorders
Headache
|
25.0%
5/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
35.0%
7/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
32.0%
16/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
40.0%
10/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
15.8%
3/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
35.3%
6/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
22.9%
8/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
26.3%
5/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.3%
1/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Nervous system disorders
Migraine
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.0%
1/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.0%
1/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
2/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
30.0%
6/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
20.0%
10/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
24.0%
6/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
10.5%
2/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
11.8%
2/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.7%
2/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
10.5%
2/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
20.0%
4/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
8.0%
4/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
24.0%
6/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.3%
1/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
11.8%
2/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.7%
2/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.3%
1/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Infections and infestations
COVID-19
|
10.0%
2/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
4.0%
2/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
8.0%
2/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.9%
1/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.3%
1/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.9%
1/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.9%
1/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Infections and infestations
Candida infection
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.3%
1/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
4.0%
1/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.9%
1/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.3%
1/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
10.0%
5/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
8.0%
2/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.9%
1/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
4.0%
2/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.0%
1/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
4.0%
1/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
5.0%
1/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.0%
1/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.9%
1/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.9%
1/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
5.0%
1/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
5.0%
1/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
4.0%
1/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Injury, poisoning and procedural complications
Limb injury
|
5.0%
1/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
4.0%
1/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
4.0%
1/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
4.0%
1/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
8.0%
2/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
4.0%
2/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.3%
1/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.0%
1/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
4.0%
2/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.3%
1/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
10.0%
2/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.0%
1/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
8.0%
2/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
4.0%
1/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
4.0%
1/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.3%
1/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
4.0%
2/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
4.0%
1/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Immune system disorders
Immunisation reaction
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
4.0%
1/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
4.0%
1/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.3%
1/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
2.0%
1/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
4.0%
1/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.3%
1/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Infections and infestations
Peritonsillar abscess
|
5.0%
1/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Infections and infestations
Tonsilitis
|
5.0%
1/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Infections and infestations
Viral infection
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
5.0%
1/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
5.0%
1/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/20 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/50 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/25 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/17 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/35 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
0.00%
0/19 • All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that there should be a joint publication first; after the joint publication or after 24 months without a joint publication from the time of last participant last visit, the PI has a right to present the trial results at meetings or do their own publication in a journal, but they must provide PATH the chance to review the manuscript 60 days in advance of publication.
- Publication restrictions are in place
Restriction type: OTHER