Trial Outcomes & Findings for First in Human Study of ChAdOx1-HBV in Healthy Participants and Participants With Chronic hepB Infection (NCT NCT04297917)
NCT ID: NCT04297917
Last Updated: 2025-08-12
Results Overview
Adverse events and/or adverse events leading to study discontinuation. Percentages are based on the number of participants in the Safety Analysis Set.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
47 participants
Primary outcome timeframe
Recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months)
Results posted on
2025-08-12
Participant Flow
Fifty-seven (57) participants were screened. Forty-seven (47) subjects were enrolled and vaccinated. The study consisted of 36 healthy participants and 11 participants with CHB and virally suppressed with oral antiviral medication.
Participant milestones
| Measure |
Healthy Volunteers With Low Dose Vaccination
5 Healthy Volunteers receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers With High Dose Vaccination
5 Healthy Volunteers receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With Low Dose Vaccination
6 participants with Chronic Hepatitis B infection receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With High Dose Vaccination
5 participants with Chronic Hepatitis B infection receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination
15 participants who have had 2 doses of COVID-19 AZD1222 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination
11 participants who have had Pfizer/Moderna mRNA COVID 19 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
6
|
5
|
15
|
11
|
|
Overall Study
COMPLETED
|
5
|
4
|
6
|
5
|
15
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
First in Human Study of ChAdOx1-HBV in Healthy Participants and Participants With Chronic hepB Infection
Baseline characteristics by cohort
| Measure |
Healthy Volunteers With Low Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers With High Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With Low Dose Vaccination
n=6 Participants
6 participants with Chronic Hepatitis B infection receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With High Dose Vaccination
n=5 Participants
5 participants with Chronic Hepatitis B infection receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine
n=15 Participants
15 participants who have had 2 doses of COVID-19 AZD1222 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine
n=11 Participants
11 participants who have had Pfizer/Moderna mRNA COVID 19 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.6 Years
STANDARD_DEVIATION 7.92 • n=99 Participants
|
38.0 Years
STANDARD_DEVIATION 5.15 • n=107 Participants
|
39.0 Years
STANDARD_DEVIATION 7.51 • n=206 Participants
|
40.8 Years
STANDARD_DEVIATION 5.63 • n=7 Participants
|
50.1 Years
STANDARD_DEVIATION 6.62 • n=31 Participants
|
50.3 Years
STANDARD_DEVIATION 6.92 • n=30 Participants
|
45.2 Years
STANDARD_DEVIATION 8.48 • n=3 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
21 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
26 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
34 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
|
Height at Screening
|
173.70 cm
STANDARD_DEVIATION 1.107 • n=99 Participants
|
172.92 cm
STANDARD_DEVIATION 5.814 • n=107 Participants
|
175.00 cm
STANDARD_DEVIATION 11.967 • n=206 Participants
|
162.20 cm
STANDARD_DEVIATION 15.515 • n=7 Participants
|
172.34 cm
STANDARD_DEVIATION 11.864 • n=31 Participants
|
170.94 cm
STANDARD_DEVIATION 8.344 • n=30 Participants
|
171.48 cm
STANDARD_DEVIATION 10.467 • n=3 Participants
|
|
Weight at Screening
|
71.18 kg
STANDARD_DEVIATION 9.030 • n=99 Participants
|
76.80 kg
STANDARD_DEVIATION 7.661 • n=107 Participants
|
69.50 kg
STANDARD_DEVIATION 10.766 • n=206 Participants
|
63.26 kg
STANDARD_DEVIATION 16.646 • n=7 Participants
|
76.65 kg
STANDARD_DEVIATION 12.988 • n=31 Participants
|
74.91 kg
STANDARD_DEVIATION 8.975 • n=30 Participants
|
73.34 kg
STANDARD_DEVIATION 11.691 • n=3 Participants
|
|
BMI at Screening
|
23.60 kg/m^2
STANDARD_DEVIATION 2.983 • n=99 Participants
|
25.62 kg/m^2
STANDARD_DEVIATION 1.377 • n=107 Participants
|
22.65 kg/m^2
STANDARD_DEVIATION 2.669 • n=206 Participants
|
23.74 kg/m^2
STANDARD_DEVIATION 3.135 • n=7 Participants
|
25.77 kg/m^2
STANDARD_DEVIATION 2.866 • n=31 Participants
|
25.66 kg/m^2
STANDARD_DEVIATION 2.862 • n=30 Participants
|
24.88 kg/m^2
STANDARD_DEVIATION 2.877 • n=3 Participants
|
PRIMARY outcome
Timeframe: Recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months)Population: Safety analysis Set
Adverse events and/or adverse events leading to study discontinuation. Percentages are based on the number of participants in the Safety Analysis Set.
Outcome measures
| Measure |
Healthy Volunteers With Low Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers With High Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With Low Dose Vaccination
n=6 Participants
6 participants with Chronic Hepatitis B infection receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With High Dose Vaccination
n=5 Participants
5 participants with Chronic Hepatitis B infection receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination
n=15 Participants
15 participants who have had 2 doses of COVID-19 AZD1222 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination
n=11 Participants
11 participants who have had Pfizer/Moderna mRNA COVID 19 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
|---|---|---|---|---|---|---|
|
Incidence of Safety and Reactogenicity Events: Adverse Events
Number of Participants with any Adverse Event
|
1 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
8 Participants
|
8 Participants
|
|
Incidence of Safety and Reactogenicity Events: Adverse Events
Number of Participants with Adverse Event leading to Study Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From day 0 to up to 6 monthsPopulation: Safety Analysis Set - all participants who received at least one vaccination.
Serious adverse events related to the study vaccine. Percentages are based on the number of participants in the Safety Analysis Set.
Outcome measures
| Measure |
Healthy Volunteers With Low Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers With High Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With Low Dose Vaccination
n=6 Participants
6 participants with Chronic Hepatitis B infection receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With High Dose Vaccination
n=5 Participants
5 participants with Chronic Hepatitis B infection receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination
n=15 Participants
15 participants who have had 2 doses of COVID-19 AZD1222 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination
n=11 Participants
11 participants who have had Pfizer/Moderna mRNA COVID 19 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
|---|---|---|---|---|---|---|
|
Incidence of Safety and Reactogenicity Events: Serious Adverse Events
Participants experiencing Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Serious Adverse Events
No Events
|
5 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
15 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: From day 0 to day 3Population: Safety Analysis Set
Local reactions were collected by the investigator pre and post vaccination on Day 0. In addition, local reactions were captured in the participant diary card on Days 1, 2 and 3. The number and percentage of participants who experienced any symptom are summarised.
Outcome measures
| Measure |
Healthy Volunteers With Low Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers With High Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With Low Dose Vaccination
n=6 Participants
6 participants with Chronic Hepatitis B infection receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With High Dose Vaccination
n=5 Participants
5 participants with Chronic Hepatitis B infection receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination
n=15 Participants
15 participants who have had 2 doses of COVID-19 AZD1222 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination
n=11 Participants
11 participants who have had Pfizer/Moderna mRNA COVID 19 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
|---|---|---|---|---|---|---|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions
Swelling - Grade ≥3 Local reactions
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions
Redness - Grade ≥3 Local reactions
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions
Pain - Grade ≥3 Local reactions
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Local Reactions
Warmth - Grade ≥3 Local reactions
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: From day 0 to day 3Population: Safety Analysis Sets
Systemic reactions were collected by the investigator pre and post vaccination on Day 0 and captured in the participant diary card on Days 1, 2 and 3. The number and percentage of participants who experienced any symptom are summarised.
Outcome measures
| Measure |
Healthy Volunteers With Low Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers With High Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With Low Dose Vaccination
n=6 Participants
6 participants with Chronic Hepatitis B infection receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With High Dose Vaccination
n=5 Participants
5 participants with Chronic Hepatitis B infection receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination
n=15 Participants
15 participants who have had 2 doses of COVID-19 AZD1222 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination
n=11 Participants
11 participants who have had Pfizer/Moderna mRNA COVID 19 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
|---|---|---|---|---|---|---|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Malaise · 4 = ER visit or hospitalisation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Headache · 1 = No interference with daily activities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Temperature · 0 = None
|
5 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
15 Participants
|
11 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Temperature · 1 = No interference with daily activities
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Temperature · 2 = Some interference with daily activities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Temperature · 3 = Significant interference with daily activities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Temperature · 4 = ER visit or hospitalisation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Muscle Ache · 0 = None
|
4 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
12 Participants
|
3 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Muscle Ache · 1 = No interference with daily activities
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
6 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Muscle Ache · 2 = Some interference with daily activities
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Muscle Ache · 3 = Significant interference with daily activities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Muscle Ache · 4 = ER visit or hospitalisation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Fatigue · 0 = None
|
4 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
14 Participants
|
6 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Fatigue · 1 = No interference with daily activities
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Fatigue · 2 = Some interference with daily activities
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Fatigue · 3 = Significant interference with daily activities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Nausea · 1 = No interference with daily activities
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Fatigue · 4 = ER visit or hospitalisation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Headache · 0 = None
|
5 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
15 Participants
|
8 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Headache · 2 = Some interference with daily activities
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Headache · 3 = Significant interference with daily activities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Headache · 4 = ER visit or hospitalisation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Nausea · 0 = None
|
5 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
15 Participants
|
11 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Nausea · 2 = Some interference with daily activities
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Nausea · 3 = Significant interference with daily activities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Nausea · 4 = ER visit or hospitalisation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Feverishness · 0 = None
|
5 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
15 Participants
|
11 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Feverishness · 1 = No interference with daily activities
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Feverishness · 2 = Some interference with daily activities
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Feverishness · 3 = Significant interference with daily activities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Feverishness · 4 = ER visit or hospitalisation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Chills · 0 = None
|
5 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
14 Participants
|
10 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Chills · 1 = No interference with daily activities
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Chills · 2 = Some interference with daily activities
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Chills · 3 = Significant interference with daily activities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Chills · 4 = ER visit or hospitalisation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Joint Ache · 0 = None
|
5 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
14 Participants
|
10 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Joint Ache · 1 = No interference with daily activities
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Joint Ache · 2 = Some interference with daily activities
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Joint Ache · 3 = Significant interference with daily activities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Joint Ache · 4 = ER visit or hospitalisation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Malaise · 0 = None
|
5 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
15 Participants
|
9 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Malaise · 1 = No interference with daily activities
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Malaise · 2 = Some interference with daily activities
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Safety and Reactogenicity Events: Grade ≥3 Systemic Reactions
Malaise · 3 = Significant interference with daily activities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 14, 28, 56, 84Intracellular cytokine staining analysis to measure IFNγ, produced by HBV antigen or hexon-specific CD8+ T cells in PBMC across study timepoints
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 28, 56, 84 and 168Population: Per Protocol population used for HBsAg changes
For the CHB participants only. HBsAg levels were measured at each scheduled follow-up timepoint (Day 28, Day 56, Day 84 and Day 168). A summary of the change is obtained by summarising the difference in the log-transformed results \[log(HbsAg at baseline + 1) - log(HbsAg at follow-up + 1)\] and back-transforming to absolute values (IU/mL). The mean change is then the Geometric Mean (GM) ratio, where a GM ratio \> 1 is equivalent to a reduction in HbsAg.
Outcome measures
| Measure |
Healthy Volunteers With Low Dose Vaccination
n=6 Participants
5 Healthy Volunteers receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers With High Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With Low Dose Vaccination
6 participants with Chronic Hepatitis B infection receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With High Dose Vaccination
5 participants with Chronic Hepatitis B infection receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination
15 participants who have had 2 doses of COVID-19 AZD1222 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination
11 participants who have had Pfizer/Moderna mRNA COVID 19 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
|---|---|---|---|---|---|---|
|
Reduction in HBsAg Titre Post-vaccination in CHB Participants
Day 28
|
1.019 ratio
Standard Deviation 1.1569
|
0.957 ratio
Standard Deviation 1.0760
|
—
|
—
|
—
|
—
|
|
Reduction in HBsAg Titre Post-vaccination in CHB Participants
Day 56
|
1.086 ratio
Standard Deviation 1.3271
|
0.814 ratio
Standard Deviation 1.4126
|
—
|
—
|
—
|
—
|
|
Reduction in HBsAg Titre Post-vaccination in CHB Participants
Day 84
|
0.984 ratio
Standard Deviation 1.3271
|
0.901 ratio
Standard Deviation 1.1471
|
—
|
—
|
—
|
—
|
|
Reduction in HBsAg Titre Post-vaccination in CHB Participants
Day 168
|
1.418 ratio
Standard Deviation 1.5074
|
1.055 ratio
Standard Deviation 1.0857
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 168Population: Intent to Treat Analysis Set
For the CHB participants only, loss of HBeAg and HBsAg at the End of Study assessment (Day 168) include all CHB participants in the denominator. Numerators include participants with a) detectable HBeAg and HBsAg at the Day 0 pre-dose assessment and b) undetectable HBeAg and HBsAg at the End of Study assessment.
Outcome measures
| Measure |
Healthy Volunteers With Low Dose Vaccination
n=6 Participants
5 Healthy Volunteers receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers With High Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With Low Dose Vaccination
6 participants with Chronic Hepatitis B infection receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With High Dose Vaccination
5 participants with Chronic Hepatitis B infection receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination
15 participants who have had 2 doses of COVID-19 AZD1222 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination
11 participants who have had Pfizer/Moderna mRNA COVID 19 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
|---|---|---|---|---|---|---|
|
Loss of Both HBeAg and HBsAg
No
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Loss of Both HBeAg and HBsAg
Yes (loss of both HBeAg and HBsAg)
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 28, 56, 84 and 168Population: ITT Analysis Set
The seroconversion of HBeAg and HBsAg is defined as loss of response to the antigen (defined as a value below the limit of detection (i.e. Not detected) and development of antibody to either HBeAg or surface antigen (HBsAg) (defined as a measurable value above the limit of detection (i.e. Detected). The number and percentage of CHB participants meeting the criteria for seroconversion will be summarised.
Outcome measures
| Measure |
Healthy Volunteers With Low Dose Vaccination
n=6 Participants
5 Healthy Volunteers receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers With High Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With Low Dose Vaccination
6 participants with Chronic Hepatitis B infection receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With High Dose Vaccination
5 participants with Chronic Hepatitis B infection receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination
15 participants who have had 2 doses of COVID-19 AZD1222 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination
11 participants who have had Pfizer/Moderna mRNA COVID 19 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
|---|---|---|---|---|---|---|
|
Proportion of CHB Participants With HBeAg and HBsAg Seroconversion
HBeAg Seroconversion · Seroconversion
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Proportion of CHB Participants With HBeAg and HBsAg Seroconversion
HBeAg Seroconversion · No Seroconversion
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Proportion of CHB Participants With HBeAg and HBsAg Seroconversion
HBsAg Seroconversion · Seroconversion
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Proportion of CHB Participants With HBeAg and HBsAg Seroconversion
HBsAg Seroconversion · No Seroconversion
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 28, 56, 84 and 168Population: Immunogenicity Analysis Set
Change in hepatitis B DNA levels is defined by subtracting the DNA levels at each follow-up visit (Day 28, Day 56, Day 84 and Day 168) from the DNA levels pre-vaccination (Day 0). A positive change is equivalent to a reduction in DNA levels. Any results recorded as Not Detected were replaced with zero prior to summarising while any recorded as Detected or 1 (the limit of detection) were replaced with 0.5, prior to summarising. The denominator is the number of participants in the analysis set.
Outcome measures
| Measure |
Healthy Volunteers With Low Dose Vaccination
n=6 Participants
5 Healthy Volunteers receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers With High Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With Low Dose Vaccination
6 participants with Chronic Hepatitis B infection receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With High Dose Vaccination
5 participants with Chronic Hepatitis B infection receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination
15 participants who have had 2 doses of COVID-19 AZD1222 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination
11 participants who have had Pfizer/Moderna mRNA COVID 19 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
|---|---|---|---|---|---|---|
|
Reduction of Hepatitis B DNA Levels in CHB Participants
Baseline
|
0.000 log 10 IU/ml
Standard Deviation 0.000
|
0.432 log 10 IU/ml
Standard Deviation 0.5942
|
—
|
—
|
—
|
—
|
|
Reduction of Hepatitis B DNA Levels in CHB Participants
Day 28
|
-0.333 log 10 IU/ml
Standard Deviation 0.4082
|
0.156 log 10 IU/ml
Standard Deviation 1.0159
|
—
|
—
|
—
|
—
|
|
Reduction of Hepatitis B DNA Levels in CHB Participants
Day 56
|
-0.455 log 10 IU/ml
Standard Deviation 0.5500
|
0.432 log 10 IU/ml
Standard Deviation 0.5942
|
—
|
—
|
—
|
—
|
|
Reduction of Hepatitis B DNA Levels in CHB Participants
Day 84
|
-0.425 log 10 IU/ml
Standard Deviation 0.5037
|
0.198 log 10 IU/ml
Standard Deviation 0.9379
|
—
|
—
|
—
|
—
|
|
Reduction of Hepatitis B DNA Levels in CHB Participants
Day 168
|
-0.333 log 10 IU/ml
Standard Deviation 0.5164
|
0.032 log 10 IU/ml
Standard Deviation 0.7649
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 14, 28, 56, and 84Population: The intention was to correlate the measure to hep B surface antigen response, which was not observed any group. We report available data for CD4+ and CD8+ magnitude from Groups 1, 2, 5, and 6. ICS assays were performed at baseline and at the timepoint of peak total response magnitude where adequate cell numbers were available (Baseline and Day 14, 28, 56, and/or 84 after dosing). No results obtained for Groups 3 and 4 due to insufficient sample volume. Certain time points were not collected.
CD4+ and CD8+ cells were analyzed at selected baseline and follow up study visits (Day 0, Day 14, Day 28, Day 56, and/or Day 84) using intracellular cytokine staining (ICS) data from a flow cytometer. Outcome 'A Multiparameter Index Made of CD4+Magnitude, CD4+ Avidity and CD8+ Magnitude' was not calculated.
Outcome measures
| Measure |
Healthy Volunteers With Low Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers With High Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With Low Dose Vaccination
6 participants with Chronic Hepatitis B infection receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With High Dose Vaccination
5 participants with Chronic Hepatitis B infection receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination
n=15 Participants
15 participants who have had 2 doses of COVID-19 AZD1222 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination
n=10 Participants
11 participants who have had Pfizer/Moderna mRNA COVID 19 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
|---|---|---|---|---|---|---|
|
Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination
CD4+ (Day 0)
|
—
|
—
|
—
|
—
|
0.019 Percentage of cells
Standard Deviation 0.021
|
0.016 Percentage of cells
Standard Deviation 0.013
|
|
Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination
CD4+ (Day 14)
|
0.013 Percentage of cells
Standard Deviation 0.013
|
0.013 Percentage of cells
Standard Deviation 0.013
|
—
|
—
|
0.015 Percentage of cells
Standard Deviation 0.016
|
0.048 Percentage of cells
Standard Deviation 0.037
|
|
Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination
CD4+ (Day 28)
|
0.013 Percentage of cells
Standard Deviation 0.003
|
0.005 Percentage of cells
Standard Deviation 0.000
|
—
|
—
|
0.017 Percentage of cells
Standard Deviation 0.013
|
0.054 Percentage of cells
Standard Deviation 0.042
|
|
Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination
CD4+ (Day 56)
|
0.001 Percentage of cells
Standard Deviation 0.000
|
0.023 Percentage of cells
Standard Deviation 0.011
|
—
|
—
|
—
|
—
|
|
Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination
CD4+ (Day 84)
|
—
|
—
|
—
|
—
|
0.020 Percentage of cells
Standard Deviation 0.015
|
0.033 Percentage of cells
Standard Deviation 0.025
|
|
Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination
CD8+ (Day 0)
|
—
|
—
|
—
|
—
|
0.055 Percentage of cells
Standard Deviation 0.085
|
0.076 Percentage of cells
Standard Deviation 0.109
|
|
Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination
CD8+ (Day 14)
|
0.022 Percentage of cells
Standard Deviation 0.014
|
0.072 Percentage of cells
Standard Deviation 0.044
|
—
|
—
|
0.073 Percentage of cells
Standard Deviation 0.125
|
1.319 Percentage of cells
Standard Deviation 3.685
|
|
Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination
CD8+ (Day 28)
|
0.046 Percentage of cells
Standard Deviation 0.022
|
0.000 Percentage of cells
Standard Deviation 0.000
|
—
|
—
|
0.063 Percentage of cells
Standard Deviation 0.074
|
2.365 Percentage of cells
Standard Deviation 7.406
|
|
Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination
CD8+ (Day 56)
|
0.293 Percentage of cells
Standard Deviation 0.000
|
0.089 Percentage of cells
Standard Deviation 0.073
|
—
|
—
|
—
|
—
|
|
Percentage of CD4+ and CD8+ Expressing IFNγ at Baseline and Days 14, 28, 56, and 84 After Vaccination
CD8+ (Day 84)
|
—
|
—
|
—
|
—
|
0.058 Percentage of cells
Standard Deviation 0.059
|
7.148 Percentage of cells
Standard Deviation 23.172
|
SECONDARY outcome
Timeframe: Baseline, Day 14, 28, 56, 84 and 168Population: Immunogenicity Analysis Set
This was determined by using PMBCs in IFN-γ ELISpot assays to investigate the breadth of HBV specific T cell responses. Assessment of immune response was based on the number of IFN-γ spot-forming units (SFU) per 10\^6 PBMC in response to stimulation with each antigenic peptide pool. For CHB-LD, CHB-HD, HP-LD, HP-HD the background correction is derived by subtracting the relevant DMSO control result and replacing any negative values or values \< 25 with zero prior to summarising.
Outcome measures
| Measure |
Healthy Volunteers With Low Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers With High Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With Low Dose Vaccination
n=6 Participants
6 participants with Chronic Hepatitis B infection receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With High Dose Vaccination
n=5 Participants
5 participants with Chronic Hepatitis B infection receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination
n=14 Participants
15 participants who have had 2 doses of COVID-19 AZD1222 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination
n=11 Participants
11 participants who have had Pfizer/Moderna mRNA COVID 19 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
|---|---|---|---|---|---|---|
|
Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Baseline
|
30.00 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 67.0820
|
0.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.000
|
0.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.0000
|
18.200 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 27.2250
|
16.111 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 32.4286
|
40.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 70.0317
|
|
Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Day 14
|
148.067 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 33.5090
|
135.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.000
|
17.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 26.3629
|
33.800 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 52.9925
|
62.341 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 72.5715
|
162.727 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 222.4751
|
|
Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Day28
|
225.667 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 161.5661
|
181.667 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.000
|
39.600 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 88.5483
|
31.400 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 70.2125
|
51.507 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 107.5817
|
96.969 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 109.7602
|
|
Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Day 56
|
99.833 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 66.5061
|
76.667 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.000
|
5.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 11.1803
|
81.600 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 83.7425
|
—
|
—
|
|
Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Day 84
|
66.333 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 81.8739
|
0.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.000
|
0.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.0000
|
43.060 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 71.5616
|
113.075 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 205.7545
|
60.302 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 65.6994
|
|
Total T Cell Response to the Core Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Day 168
|
49.667 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 68.3171
|
38.333 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.000
|
6.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 13.4164
|
14.200 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 31.7522
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 14, 28, 56, 84 and 168Population: Immunogenicity Analysis Set
This was determined by using PMBCs in IFN-γ ELISpot assays to investigate the breadth of HBV specific T cell responses. Assessment of immune response was based on the number of IFN-γ spot-forming units (SFU) per 10\^6 PBMC in response to stimulation with each antigenic peptide pool. For CHB-LD, CHB-HD, HP-LD, HP-HD the background correction is derived by subtracting the relevant DMSO control result and replacing any negative values or values \< 25 with zero prior to summarising.
Outcome measures
| Measure |
Healthy Volunteers With Low Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers With High Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With Low Dose Vaccination
n=6 Participants
6 participants with Chronic Hepatitis B infection receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With High Dose Vaccination
n=5 Participants
5 participants with Chronic Hepatitis B infection receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination
n=15 Participants
15 participants who have had 2 doses of COVID-19 AZD1222 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination
n=11 Participants
11 participants who have had Pfizer/Moderna mRNA COVID 19 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
|---|---|---|---|---|---|---|
|
Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Baseline
|
61.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 87.4929
|
22.500 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 31.8198
|
6.200 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 13.8636
|
11.600 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 25.9384
|
0.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.000
|
0.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.000
|
|
Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Day 14
|
459.600 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 190.4637
|
680.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.000
|
64.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 95.8775
|
13.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 29.0689
|
15.317 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 39.9482
|
252.727 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 347.2137
|
|
Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Day 28
|
585.333 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 207.7338
|
853.333 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.000
|
102.200 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 206.8918
|
44.600 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 85.9349
|
5.238 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 19.5992
|
134.090 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 203.8124
|
|
Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Day 56
|
143.333 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 94.4410
|
670.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.000
|
55.800 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 103.8663
|
130.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 262.5871
|
—
|
—
|
|
Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Day 84
|
254.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 142.9773
|
385.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.000
|
74.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 111.2654
|
15.600 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 34.8827
|
40.513 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 122.9345
|
68.485 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 124.9477
|
|
Total T Cell Response to the Pol1-Pol4 Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Day 168
|
209.333 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 144.9119
|
260.833 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.000
|
0.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.0000
|
7.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 15.6525
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 14, 28, 56, 84 and 168Population: Immunogenicity Analysis Set
This was determined by using PMBCs in IFN-γ ELISpot assays to investigate the breadth of HBV specific T cell responses. Assessment of immune response was based on the number of IFN-γ spot-forming units (SFU) per 10\^6 PBMC in response to stimulation with each antigenic peptide pool. For CHB-LD, CHB-HD, HP-LD, HP-HD the background correction is derived by subtracting the relevant DMSO control result and replacing any negative values or values \< 25 with zero prior to summarising.
Outcome measures
| Measure |
Healthy Volunteers With Low Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers With High Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With Low Dose Vaccination
n=6 Participants
6 participants with Chronic Hepatitis B infection receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With High Dose Vaccination
n=5 Participants
5 participants with Chronic Hepatitis B infection receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination
n=14 Participants
15 participants who have had 2 doses of COVID-19 AZD1222 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination
n=11 Participants
11 participants who have had Pfizer/Moderna mRNA COVID 19 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
|---|---|---|---|---|---|---|
|
Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Baseline
|
279.167 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 296.0316
|
10.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 17.3205
|
38.200 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 70.8110
|
20.200 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 31.2282
|
46.349 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 76.7025
|
86.364 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 101.3734
|
|
Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Day 14
|
613.967 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 195.7494
|
918.750 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 429.5674
|
32.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 19.0263
|
35.400 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 50.2076
|
94.444 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 100.6059
|
191.818 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 124.9388
|
|
Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Day 28
|
691.167 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 164.1345
|
723.750 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 121.9759
|
25.600 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 57.2433
|
5.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 11.1803
|
77.698 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 88.9171
|
163.787 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 108.5050
|
|
Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Day 56
|
385.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 173.8813
|
873.333 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 546.8292
|
25.400 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 26.1878
|
109.600 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 220.7788
|
—
|
—
|
|
Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Day 84
|
341.333 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 147.7958
|
348.750 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 113.7263
|
32.600 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 51.2133
|
19.660 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 27.2365
|
100.256 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 174.3531
|
79.394 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 76.1256
|
|
Total T Cell Response to the Pre S1/S2 Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Day 168
|
229.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 142.8947
|
353.333 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 124.9222
|
24.800 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 36.7859
|
12.200 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 17.1523
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 14, 28, 56, 84 and 168Population: Immunogenicity Analysis Set
This was determined by using PMBCs in IFN-γ ELISpot assays to investigate the breadth of HBV specific T cell responses. Assessment of immune response was based on the number of IFN-γ spot-forming units (SFU) per 10\^6 PBMC in response to stimulation with each antigenic peptide pool. For CHB-LD, CHB-HD, HP-LD, HP-HD the background correction is derived by subtracting the relevant DMSO control result and replacing any negative values or values \< 25 with zero prior to summarising.
Outcome measures
| Measure |
Healthy Volunteers With Low Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers With High Dose Vaccination
n=5 Participants
5 Healthy Volunteers receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With Low Dose Vaccination
n=6 Participants
6 participants with Chronic Hepatitis B infection receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With High Dose Vaccination
n=5 Participants
5 participants with Chronic Hepatitis B infection receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination
n=14 Participants
15 participants who have had 2 doses of COVID-19 AZD1222 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination
n=11 Participants
11 participants who have had Pfizer/Moderna mRNA COVID 19 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
|---|---|---|---|---|---|---|
|
Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Baseline
|
12.500 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 25.0000
|
—
|
0.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.0000
|
5.600 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 12.5220
|
—
|
—
|
|
Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Day 14
|
179.042 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 285.1818
|
—
|
5.600 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 12.5220
|
0.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.0000
|
—
|
—
|
|
Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Day 28
|
322.500 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 506.5872
|
—
|
0.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.0000
|
5.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 11.1803
|
—
|
—
|
|
Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Day 56
|
98.750 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 197.5000
|
—
|
0.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.0000
|
38.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 84.9706
|
—
|
—
|
|
Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Day 84
|
119.583 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 239.1667
|
—
|
0.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.0000
|
0.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.0000
|
—
|
—
|
|
Total T Cell Response to the Sii Surface Antigen Encoded by ChAdOx1-HBV as Measured in a Peptide-stimulated ELISpot Assay
Day 168
|
91.250 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 182.5000
|
—
|
0.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.0000
|
0.000 Spot forming units (SFU) per 10^6 PBMC
Standard Deviation 0.0000
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 14, 28, 84Population: Immunogenicity Analysis Set
Intracellular cytokine staining analysis to measure IFNγ, produced by hexon-specific CD4+ T cells in PBMC across study timepoints
Outcome measures
| Measure |
Healthy Volunteers With Low Dose Vaccination
n=15 Participants
5 Healthy Volunteers receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers With High Dose Vaccination
n=11 Participants
5 Healthy Volunteers receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With Low Dose Vaccination
6 participants with Chronic Hepatitis B infection receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With High Dose Vaccination
5 participants with Chronic Hepatitis B infection receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination
15 participants who have had 2 doses of COVID-19 AZD1222 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination
11 participants who have had Pfizer/Moderna mRNA COVID 19 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
|---|---|---|---|---|---|---|
|
Effect of Prior AZD1222 on the CD4+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry
CD4+ IFNy+ Day 0
|
0.018525 Mean CD4+ IFNy+ T cells
Standard Deviation 0.02152
|
0.016409 Mean CD4+ IFNy+ T cells
Standard Deviation 0.014048
|
—
|
—
|
—
|
—
|
|
Effect of Prior AZD1222 on the CD4+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry
CD4+ IFNy+ Day 14
|
0.014959 Mean CD4+ IFNy+ T cells
Standard Deviation 0.016946
|
0.047705 Mean CD4+ IFNy+ T cells
Standard Deviation 0.03924
|
—
|
—
|
—
|
—
|
|
Effect of Prior AZD1222 on the CD4+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry
CD4+ IFNy+ Day 28
|
0.017065 Mean CD4+ IFNy+ T cells
Standard Deviation 0.013149
|
0.054382 Mean CD4+ IFNy+ T cells
Standard Deviation 0.04386
|
—
|
—
|
—
|
—
|
|
Effect of Prior AZD1222 on the CD4+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry
CD4+ IFNy+ Day 84
|
0.020178 Mean CD4+ IFNy+ T cells
Standard Deviation 0.015547
|
0.033339 Mean CD4+ IFNy+ T cells
Standard Deviation 0.026769
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 14, 28, 84Population: Immunogenicity Analysis Set
Intracellular cytokine staining analysis to measure IFNγ, produced by hexon-specific CD8+ T cells in PBMC across study timepoints
Outcome measures
| Measure |
Healthy Volunteers With Low Dose Vaccination
n=15 Participants
5 Healthy Volunteers receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers With High Dose Vaccination
n=1 Participants
5 Healthy Volunteers receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With Low Dose Vaccination
6 participants with Chronic Hepatitis B infection receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With High Dose Vaccination
5 participants with Chronic Hepatitis B infection receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination
15 participants who have had 2 doses of COVID-19 AZD1222 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination
11 participants who have had Pfizer/Moderna mRNA COVID 19 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
|---|---|---|---|---|---|---|
|
Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry
CD8+ IFNy+ Day 0
|
0.055028 Mean CD8+ IFNy+ T cells
Standard Deviation 0.088611
|
0.085174 Mean CD8+ IFNy+ T cells
Standard Deviation 0.130337
|
—
|
—
|
—
|
—
|
|
Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry
CD8+ IFNy+ Day 14
|
0.073259 Mean CD8+ IFNy+ T cells
Standard Deviation 0.129767
|
0.295344 Mean CD8+ IFNy+ T cells
Standard Deviation 0.506428
|
—
|
—
|
—
|
—
|
|
Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry
CD8+ IFNy+ Day 28
|
0.062521 Mean CD8+ IFNy+ T cells
Standard Deviation 0.076278
|
0.261003 Mean CD8+ IFNy+ T cells
Standard Deviation 0.34742
|
—
|
—
|
—
|
—
|
|
Effect of Prior AZD1222 on the CD8+ T Cell Magnitude and Phenotype as Measured by Multiparameter Flow Cytometry
CD8+ IFNy+ Day 84
|
0.057933 Mean CD8+ IFNy+ T cells
Standard Deviation 0.061425
|
0.183798 Mean CD8+ IFNy+ T cells
Standard Deviation 0.145222
|
—
|
—
|
—
|
—
|
Adverse Events
Healthy Volunteers With Low Dose Vaccination
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Healthy Volunteers With High Dose Vaccination
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Chronic Hepatitis B Participants With Low Dose Vaccination
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Chronic Hepatitis B Participants With High Dose Vaccination
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Volunteers With Low Dose Vaccination
n=5 participants at risk
5 Healthy Volunteers receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers With High Dose Vaccination
n=5 participants at risk
5 Healthy Volunteers receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With Low Dose Vaccination
n=6 participants at risk
6 participants with Chronic Hepatitis B infection receiving low dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Chronic Hepatitis B Participants With High Dose Vaccination
n=5 participants at risk
5 participants with Chronic Hepatitis B infection receiving high dose vaccination
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had COVID-19 AZD1222 Vaccine Received High Dose Vaccination
n=15 participants at risk
15 participants who have had 2 doses of COVID-19 AZD1222 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
Healthy Volunteers Who Have Had Pfizer/Moderna mRNA COVID 19 Vaccine Received High Dose Vaccination
n=11 participants at risk
11 participants who have had Pfizer/Moderna mRNA COVID 19 vaccine
ChAdOx1-HBV: chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
|---|---|---|---|---|---|---|
|
General disorders
Injection site pain
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
60.0%
3/5 • Number of events 3 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
18.2%
2/11 • Number of events 2 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
General disorders
Injection site swelling
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
6.7%
1/15 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
18.2%
2/11 • Number of events 2 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
General disorders
Chills
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
20.0%
1/5 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
9.1%
1/11 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
General disorders
Injection site erythema
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
18.2%
2/11 • Number of events 2 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
General disorders
Peripheral swelling
|
20.0%
1/5 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
9.1%
1/11 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
General disorders
Fatigue
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
20.0%
1/5 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/11 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
General disorders
Injection site rash
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
9.1%
1/11 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
General disorders
Injection site warmth
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
20.0%
1/5 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/11 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
General disorders
Malaise
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
20.0%
1/5 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/11 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
General disorders
Pain
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
9.1%
1/11 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
20.0%
1/5 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/11 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
20.0%
1/5 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
33.3%
5/15 • Number of events 5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
18.2%
2/11 • Number of events 2 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
16.7%
1/6 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
6.7%
1/15 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/11 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
20.0%
1/5 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/11 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
20.0%
3/15 • Number of events 3 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
9.1%
1/11 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Infections and infestations
Influenza
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
20.0%
1/5 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/11 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
9.1%
1/11 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
6.7%
1/15 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/11 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Skin and subcutaneous tissue disorders
Erythrma
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
18.2%
2/11 • Number of events 2 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
9.1%
1/11 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
6.7%
1/15 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/11 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
9.1%
1/11 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
6.7%
1/15 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/11 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
20.0%
1/5 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/11 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
20.0%
1/5 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/11 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
20.0%
1/5 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/11 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
20.0%
1/5 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/11 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
9.1%
1/11 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
20.0%
1/5 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/11 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
9.1%
1/11 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
9.1%
1/11 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
16.7%
1/6 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/11 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Eye disorders
Vision blurred
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/6 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
20.0%
1/5 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/11 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
16.7%
1/6 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/11 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
|
Surgical and medical procedures
Laparoscopic surgery
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
16.7%
1/6 • Number of events 1 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/5 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/15 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
0.00%
0/11 • Unsolicited adverse events will be recorded in the eCRF from the date the informed consent is signed, at all clinic visits (D0, D1, D7, D14, D28, D56, D84) to cover the period since the previous visit and during the visit and up to 168 days post-vaccination (6 months). Unsolicited adverse events will be followed until resolved or until participant contact discontinues.
Adverse events were coded using MedDRA. Treatment-emergent adverse events (TEAEs) are defined as those occurring or worsening after the study vaccine administration. TEAEs are summarised by system organ class (SOC) and by preferred term (PT). The incidence of TEAEs is based on the numbers and percentages of participants with events and number of events. TEAEs are further summarised by severity and relationship to study vaccine.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60