Trial Outcomes & Findings for African-Canadian Study of HIV-Infected Adults and a Vaccine for Ebola - ACHIV-Ebola (NCT NCT03031912)
NCT ID: NCT03031912
Last Updated: 2026-01-12
Results Overview
The number of participants with general solicited local (at the injection site) and systemic adverse events following vaccination will be summarized. Local AES include: pain at injection site, redness at injection site, swelling at injection site Systemic AEs include: fever, arthritis, arthralgia, rash and blisters/vesicular lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
251 participants
Primary outcome timeframe
From vaccine administration up to day 14 following vaccination
Results posted on
2026-01-12
Participant Flow
Changes made as requested by PRS team. Results have been provided for each arm of each cohort.
Participant milestones
| Measure |
Cohort 1: V920
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥500 cells/mm3
Adults.
|
Cohort 1: Placebo
Participants randomly assigned to receive placebo control.
≥500 cells/mm3
Adults.
|
Cohort 2: V920
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
\>350 and \<500 cells/mm3
Adults.
|
Cohort 2: Placebo
Participants randomly assigned to receive placebo control.
\>350 and \<500 cells/mm3
Adults.
|
Cohort 3: V920
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 and ≤350 cells/mm3
Adults.
|
Cohort 3: Placebo
Participants randomly assigned to receive placebo control.
≥200 and ≤350 cells/mm3
Adults.
|
Cohort 4: V920
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 cells/mm3
Adolescents.
|
Cohort 4: Placebo
Participants randomly assigned to receive placebo control.
≥200 cells/mm3
Adolescents.
|
Cohort 5: V920
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 cells/mm3
Adults and adolescents.
|
Cohort 5: Placebo
Participants randomly assigned to receive placebo control.
≥200 cells/mm3
Adults and adolescents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
10
|
40
|
10
|
41
|
9
|
40
|
10
|
40
|
10
|
|
Overall Study
COMPLETED
|
40
|
9
|
40
|
9
|
41
|
9
|
40
|
10
|
40
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: V920
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥500 cells/mm3
Adults.
|
Cohort 1: Placebo
Participants randomly assigned to receive placebo control.
≥500 cells/mm3
Adults.
|
Cohort 2: V920
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
\>350 and \<500 cells/mm3
Adults.
|
Cohort 2: Placebo
Participants randomly assigned to receive placebo control.
\>350 and \<500 cells/mm3
Adults.
|
Cohort 3: V920
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 and ≤350 cells/mm3
Adults.
|
Cohort 3: Placebo
Participants randomly assigned to receive placebo control.
≥200 and ≤350 cells/mm3
Adults.
|
Cohort 4: V920
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 cells/mm3
Adolescents.
|
Cohort 4: Placebo
Participants randomly assigned to receive placebo control.
≥200 cells/mm3
Adolescents.
|
Cohort 5: V920
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 cells/mm3
Adults and adolescents.
|
Cohort 5: Placebo
Participants randomly assigned to receive placebo control.
≥200 cells/mm3
Adults and adolescents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
African-Canadian Study of HIV-Infected Adults and a Vaccine for Ebola - ACHIV-Ebola
Baseline characteristics by cohort
| Measure |
Cohort 1: V920
n=41 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine
Adults: CD4 cells/mm3 ≥ 500
1
|
Cohort 1: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
Adults: CD4 cells/mm3 ≥ 500
1
|
Cohort 2: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine
Adults: CD4 cells/mm3 \>350 and \< 500
|
Cohort 2: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
Adults: CD4 cells/mm3 \>350 and \< 500
|
Cohort 3: V920
n=41 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine
Adults: CD4 cells/mm3 ≥ 200 and ≤ 350
|
Cohort 3: Placebo
n=9 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
Adults: CD4 cells/mm3 ≥ 200 and ≤ 350
|
Cohort 4: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine
Adolescents: CD4 cells/mm3 ≥ 200
|
Cohort 4: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
Adolescents: CD4 cells/mm3 ≥ 200
|
Cohort 5: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine
Adults and adolescents: CD4 cells/mm3 ≥ 200
|
Cohort 5: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
Adults and adolescents: CD4 cells/mm3 ≥ 200
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=5716 Participants
|
0 Participants
n=47026 Participants
|
40 Participants
n=66536 Participants
|
10 Participants
n=335 Participants
|
12 Participants
n=451 Participants
|
3 Participants
n=6 Participants
|
65 Participants
n=77 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=210 Participants
|
10 Participants
n=19 Participants
|
39 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
41 Participants
n=5716 Participants
|
9 Participants
n=47026 Participants
|
0 Participants
n=66536 Participants
|
0 Participants
n=335 Participants
|
28 Participants
n=451 Participants
|
7 Participants
n=6 Participants
|
184 Participants
n=77 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=5716 Participants
|
0 Participants
n=47026 Participants
|
0 Participants
n=66536 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=77 Participants
|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 8.0 • n=210 Participants
|
48.9 years
STANDARD_DEVIATION 8.6 • n=19 Participants
|
48.1 years
STANDARD_DEVIATION 8.3 • n=8 Participants
|
49.9 years
STANDARD_DEVIATION 7 • n=24 Participants
|
46.6 years
STANDARD_DEVIATION 11.1 • n=5716 Participants
|
44.1 years
STANDARD_DEVIATION 8.8 • n=47026 Participants
|
15 years
STANDARD_DEVIATION 1.5 • n=66536 Participants
|
14.5 years
STANDARD_DEVIATION 1.4 • n=335 Participants
|
33.1 years
STANDARD_DEVIATION 15.2 • n=451 Participants
|
33.8 years
STANDARD_DEVIATION 19 • n=6 Participants
|
44 years
STANDARD_DEVIATION 16.7 • n=77 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=210 Participants
|
6 Participants
n=19 Participants
|
24 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
18 Participants
n=5716 Participants
|
6 Participants
n=47026 Participants
|
20 Participants
n=66536 Participants
|
7 Participants
n=335 Participants
|
21 Participants
n=451 Participants
|
4 Participants
n=6 Participants
|
130 Participants
n=77 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=210 Participants
|
4 Participants
n=19 Participants
|
16 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
23 Participants
n=5716 Participants
|
3 Participants
n=47026 Participants
|
20 Participants
n=66536 Participants
|
3 Participants
n=335 Participants
|
19 Participants
n=451 Participants
|
6 Participants
n=6 Participants
|
121 Participants
n=77 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
21 Participants
n=210 Participants
|
5 Participants
n=19 Participants
|
39 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
41 Participants
n=5716 Participants
|
9 Participants
n=47026 Participants
|
40 Participants
n=66536 Participants
|
10 Participants
n=335 Participants
|
40 Participants
n=451 Participants
|
10 Participants
n=6 Participants
|
225 Participants
n=77 Participants
|
|
Race/Ethnicity, Customized
Race · Multiple - Asian, White
|
0 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=5716 Participants
|
0 Participants
n=47026 Participants
|
0 Participants
n=66536 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=77 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
20 Participants
n=210 Participants
|
4 Participants
n=19 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=5716 Participants
|
0 Participants
n=47026 Participants
|
0 Participants
n=66536 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
25 Participants
n=77 Participants
|
|
Region of Enrollment
Canada
|
20 Participants
n=210 Participants
|
5 Participants
n=19 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=5716 Participants
|
0 Participants
n=47026 Participants
|
0 Participants
n=66536 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
26 Participants
n=77 Participants
|
|
Region of Enrollment
Burkina Faso
|
12 Participants
n=210 Participants
|
3 Participants
n=19 Participants
|
23 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
25 Participants
n=5716 Participants
|
6 Participants
n=47026 Participants
|
38 Participants
n=66536 Participants
|
9 Participants
n=335 Participants
|
24 Participants
n=451 Participants
|
6 Participants
n=6 Participants
|
152 Participants
n=77 Participants
|
|
Region of Enrollment
Senegal
|
9 Participants
n=210 Participants
|
2 Participants
n=19 Participants
|
16 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
16 Participants
n=5716 Participants
|
3 Participants
n=47026 Participants
|
2 Participants
n=66536 Participants
|
1 Participants
n=335 Participants
|
16 Participants
n=451 Participants
|
4 Participants
n=6 Participants
|
73 Participants
n=77 Participants
|
PRIMARY outcome
Timeframe: From vaccine administration up to day 14 following vaccinationThe number of participants with general solicited local (at the injection site) and systemic adverse events following vaccination will be summarized. Local AES include: pain at injection site, redness at injection site, swelling at injection site Systemic AEs include: fever, arthritis, arthralgia, rash and blisters/vesicular lesions.
Outcome measures
| Measure |
Cohort 1: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥500 cells/mm3 Adults.
|
Cohort 1: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥500 cells/mm3 Adults.
|
Cohort 2: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
\>350 and \<500 cells/mm3 Adults.
|
Cohort 2: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
\>350 and \<500 cells/mm3 Adults.
|
Cohort 3: V920
n=41 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 and ≤350 cells/mm3 Adults.
|
Cohort 3: Placebo
n=9 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 and ≤350 cells/mm3 Adults.
|
Cohort 4: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 cells/mm3 Adolescents.
|
Cohort 4: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 cells/mm3 Adolescents.
|
Cohort 5: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 cells/mm3 Adults and adolescents.
|
Cohort 5: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 cells/mm3 Adults and adolescents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Local - injection site erythema
|
5 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Local - Injection site pain
|
22 Participants
|
3 Participants
|
20 Participants
|
3 Participants
|
24 Participants
|
1 Participants
|
34 Participants
|
3 Participants
|
30 Participants
|
2 Participants
|
|
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Local - Injection site swelling
|
4 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Systemic - Abdominal pain
|
4 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
8 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Systemic - Arthralgia
|
14 Participants
|
0 Participants
|
16 Participants
|
2 Participants
|
7 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
10 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Systemic - Blister
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Systemic - Chills
|
14 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
8 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Systemic - Diarrhea
|
10 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Systemic - Fatigue
|
21 Participants
|
3 Participants
|
18 Participants
|
5 Participants
|
24 Participants
|
1 Participants
|
8 Participants
|
1 Participants
|
20 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Systemic - Headache
|
23 Participants
|
4 Participants
|
21 Participants
|
2 Participants
|
20 Participants
|
2 Participants
|
22 Participants
|
5 Participants
|
23 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Systemic - Feeling hot
|
11 Participants
|
0 Participants
|
7 Participants
|
2 Participants
|
8 Participants
|
1 Participants
|
10 Participants
|
3 Participants
|
15 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Systemic - Hyperhidrosis
|
11 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
7 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Systemic - Joint swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Systemic - Myalgia
|
12 Participants
|
2 Participants
|
8 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
10 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Systemic - Nausea
|
10 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
9 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Systemic - Pyrexia
|
5 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Systemic - Rash
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From vaccine administration up to 42 days postvaccinationThe number of participants with solicited systemic adverse events following vaccination that include arthralgia, blister, joint swelling, pyrexia and rash
Outcome measures
| Measure |
Cohort 1: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥500 cells/mm3 Adults.
|
Cohort 1: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥500 cells/mm3 Adults.
|
Cohort 2: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
\>350 and \<500 cells/mm3 Adults.
|
Cohort 2: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
\>350 and \<500 cells/mm3 Adults.
|
Cohort 3: V920
n=41 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 and ≤350 cells/mm3 Adults.
|
Cohort 3: Placebo
n=9 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 and ≤350 cells/mm3 Adults.
|
Cohort 4: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 cells/mm3 Adolescents.
|
Cohort 4: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 cells/mm3 Adolescents.
|
Cohort 5: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 cells/mm3 Adults and adolescents.
|
Cohort 5: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 cells/mm3 Adults and adolescents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Joint swelling
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Pyrexia
|
8 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Rash
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Blister
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events Following V920 Vaccination
Arthralgia
|
9 Participants
|
2 Participants
|
15 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From vaccine administration up to day 42 postvaccinationThe number of participants with unsolicited adverse events following vaccination. These include the following disorders: Blood and lymphatic system disorders, cardiac disorders, ear and labyrinth disorders, eye disorders, gastrointestinal disorders, general disorders and administration site conditions, infections and infestations, injury, poisoning and procedural complications, metabolism and nutrition disorders, musculoskeletal and connective tissue disorders, nervous system disorders, psychiatric disorders, reproductive system and breast disorders, respiratory, thoracic and mediastinal disorders, skin and subcutaneous tissue disorders,vascular disorders.
Outcome measures
| Measure |
Cohort 1: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥500 cells/mm3 Adults.
|
Cohort 1: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥500 cells/mm3 Adults.
|
Cohort 2: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
\>350 and \<500 cells/mm3 Adults.
|
Cohort 2: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
\>350 and \<500 cells/mm3 Adults.
|
Cohort 3: V920
n=41 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 and ≤350 cells/mm3 Adults.
|
Cohort 3: Placebo
n=9 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 and ≤350 cells/mm3 Adults.
|
Cohort 4: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 cells/mm3 Adolescents.
|
Cohort 4: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 cells/mm3 Adolescents.
|
Cohort 5: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 cells/mm3 Adults and adolescents.
|
Cohort 5: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 cells/mm3 Adults and adolescents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Nervous system disorders - Burning sensation
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Nervous system disorders - Carpal tunnel syndrome
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Blood and lymphatic system disorders - Lymphadenopathy
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Cardiac disorders - Angina pectoris
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Ear and labyrinth disorders - Cerumen impaction
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Pneumonia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Eye disorders - Conjunctivitis allergic
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Rhinitis
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Eye disorders - Eye irritation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Eye disorders - Eye pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Gastrointestinal disorders - Abdominal pain
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Gastrointestinal disorders - Diarrhea
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Gastrointestinal disorders - Abdominal pain upper
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Gastrointestinal disorders - Dental caries
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Gastrointestinal disorders - Dyspepsia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Gastrointestinal disorders - Gastroduodenal ulcer
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Gastrointestinal disorders - Gastrointestinal disorder
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Gastrointestinal disorders - Malpositioned teeth
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Gastrointestinal disorders - Oral papule
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Gastrointestinal disorders - Peptic ulcer
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Gastrointestinal disorders - Toothache
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
General disorders and administration site conditions - Chest pain
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
General disorders and administration site conditions - Fatigue
|
6 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
General disorders and administration site conditions - Ill-defined disorder
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
General disorders and administration site conditions - Injection site induration
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
General disorders and administration site conditions - Pain
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
General disorders and administration site conditions - Tenderness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Amoebic dysentery
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Bronchitis
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Cystitis
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Conjunctivitis
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Conjunctivitis bacterial
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Cutaneous leishmaniasis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Furuncle
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Gastroenteritis
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Influenza
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Malaria
|
5 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Nasopharyngitis
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Orchitis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Otitis media chronic
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Parasitic gastroenteritis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Paronychia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Pilonidal disease
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Sinobronchitis
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Metabolism and nutrition disorders - Decreased appetite
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Tinea pedis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Nervous system disorders - Paraesthesia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Tonsillitis
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Tooth abscess
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Tooth infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Nervous system disorders - Sciatica
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Typhoid fever
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Upper respiratory tract infection
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Urinary tract infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Infections and infestations - Vulvovaginal mycotic infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Injury, poisoning and procedural complications -Ankle fracture
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Injury, poisoning and procedural complications - Limb injury
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Injury, poisoning and procedural complications - Thermal burn
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Musculoskeletal and connective tissue disorders - Back pain
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Nervous system disorders - Cervicobrachial syndrome
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Nervous system disorders - Intercostal neuralgia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Psychiatric disorders - Insomnia
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Reproductive system and breast disorders - Breast pain
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Reproductive system and breast disorders - Dysmenorrhoea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Reproductive system and breast disorders - Heavy menstrual bleeding
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Reproductive system and breast disorders - Vaginal discharge
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Respiratory, thoracic and mediastinal disorders - Bronchopneumopathy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Respiratory, thoracic and mediastinal disorders - Cough
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Respiratory, thoracic and mediastinal disorders - Lung disorder
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Respiratory, thoracic and mediastinal disorders - Oropharyngeal pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Skin and subcutaneous tissue disorders - Acne
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Nervous system disorders - Dizziness
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Nervous system disorders - Headache
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Musculoskeletal and connective tissue disorders - Bursitis
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Musculoskeletal and connective tissue disorders - Myalgia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Musculoskeletal and connective tissue disorders - Torticollis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Skin and subcutaneous tissue disorders - Hyperhidrosis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Musculoskeletal and connective tissue disorders - Pain in extremity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Skin and subcutaneous tissue disorders - Intertrigo
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Skin and subcutaneous tissue disorders - Prurigo
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Skin and subcutaneous tissue disorders - Pruritus
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Vascular disorders - Diastolic hypertension
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Vascular disorders - Hypertension
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events Following V920 Vaccination
Skin and subcutaneous tissue disorders - Ecchymosis
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From vaccine administration up to day 365 following vaccinationThe number of participants with solicited vaccine-related serious adverse events following V920 vaccination.
Outcome measures
| Measure |
Cohort 1: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥500 cells/mm3 Adults.
|
Cohort 1: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥500 cells/mm3 Adults.
|
Cohort 2: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
\>350 and \<500 cells/mm3 Adults.
|
Cohort 2: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
\>350 and \<500 cells/mm3 Adults.
|
Cohort 3: V920
n=41 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 and ≤350 cells/mm3 Adults.
|
Cohort 3: Placebo
n=9 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 and ≤350 cells/mm3 Adults.
|
Cohort 4: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 cells/mm3 Adolescents.
|
Cohort 4: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 cells/mm3 Adolescents.
|
Cohort 5: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 cells/mm3 Adults and adolescents.
|
Cohort 5: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 cells/mm3 Adults and adolescents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events Following V920 Vaccination
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 28 postvaccinationGeometric Mean Titers (GMTs) for ZEBOV-specific antibodies at Day 28 were calculated for each treatment group, along with two-sided 95% CIs, by exponentiating the corresponding log-transformed mean and two-sided 95% confidence limits. Cohorts 1-5.
Outcome measures
| Measure |
Cohort 1: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥500 cells/mm3 Adults.
|
Cohort 1: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥500 cells/mm3 Adults.
|
Cohort 2: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
\>350 and \<500 cells/mm3 Adults.
|
Cohort 2: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
\>350 and \<500 cells/mm3 Adults.
|
Cohort 3: V920
n=41 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 and ≤350 cells/mm3 Adults.
|
Cohort 3: Placebo
n=9 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 and ≤350 cells/mm3 Adults.
|
Cohort 4: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 cells/mm3 Adolescents.
|
Cohort 4: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 cells/mm3 Adolescents.
|
Cohort 5: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 cells/mm3 Adults and adolescents.
|
Cohort 5: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 cells/mm3 Adults and adolescents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers Induced by V920
|
1655.0 Titer
|
18.1 Titer
Interval 8.7 to 37.3
|
1124.6 Titer
Interval 821.0 to
|
26.8 Titer
Interval 13.8 to 52.0
|
868.8 Titer
Interval 679.0 to
|
29.7 Titer
Interval 17.5 to 50.2
|
1432.8 Titer
|
30.4 Titer
Interval 17.6 to 52.4
|
1191.8 Titer
Interval 865.7 to
|
43.1 Titer
Interval 22.8 to 81.8
|
PRIMARY outcome
Timeframe: 28 days after LAST (second) dose of vaccineGeometric Mean Titers (GMTs) for ZEBOV-specific antibodies at Day 28 were calculated for each treatment group, along with two-sided 95% CIs, by exponentiating the corresponding log-transformed mean and two-sided 95% confidence limits Only Cohort 5 received 2 doses of vaccine.
Outcome measures
| Measure |
Cohort 1: V920
n=40 Participants
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥500 cells/mm3 Adults.
|
Cohort 1: Placebo
n=10 Participants
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥500 cells/mm3 Adults.
|
Cohort 2: V920
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
\>350 and \<500 cells/mm3 Adults.
|
Cohort 2: Placebo
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
\>350 and \<500 cells/mm3 Adults.
|
Cohort 3: V920
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 and ≤350 cells/mm3 Adults.
|
Cohort 3: Placebo
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 and ≤350 cells/mm3 Adults.
|
Cohort 4: V920
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 cells/mm3 Adolescents.
|
Cohort 4: Placebo
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 cells/mm3 Adolescents.
|
Cohort 5: V920
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 cells/mm3 Adults and adolescents.
|
Cohort 5: Placebo
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 cells/mm3 Adults and adolescents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers Induced by V920
|
8,416.0 Titer
|
40.3 Titer
Interval 23.8 to 68.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1: V920
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Cohort 1: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2: V920
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort 2: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 3: V920
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 3: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 4: V920
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Cohort 4: Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 5: V920
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort 5: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: V920
n=40 participants at risk
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine
≥500 cells/mm3 Adults.
|
Cohort 1: Placebo
n=10 participants at risk
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥500 cells/mm3 Adults.
|
Cohort 2: V920
n=40 participants at risk
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
\>350 and \<500 cells/mm3 Adults.
|
Cohort 2: Placebo
n=10 participants at risk
Participants randomly assigned to receive placebo. Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
\>350 and \<500 cells/mm3 Adults.
|
Cohort 3: V920
n=41 participants at risk
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 and ≤350 cells/mm3 Adults.
|
Cohort 3: Placebo
n=9 participants at risk
Participants randomly assigned to receive placebo. Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 and ≤350 cells/mm3 Adults.
|
Cohort 4: V920
n=40 participants at risk
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 cells/mm3 Adolescents.
|
Cohort 4: Placebo
n=10 participants at risk
Participants randomly assigned to receive placebo. Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 cells/mm3 Adolescents.
|
Cohort 5: V920
n=40 participants at risk
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 cells/mm3 Adults and adolescents.
|
Cohort 5: Placebo
n=10 participants at risk
Participants randomly assigned to receive placebo. Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 cells/mm3 Adults and adolescents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Hepatitis toxic
|
2.5%
1/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Infections and infestations
Erysipelas
|
2.5%
1/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Infections and infestations
Malaria
|
2.5%
1/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Vascular disorders
Thrombophlebitis
|
2.5%
1/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
2.4%
1/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
Other adverse events
| Measure |
Cohort 1: V920
n=40 participants at risk
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine
≥500 cells/mm3 Adults.
|
Cohort 1: Placebo
n=10 participants at risk
Participants randomly assigned to receive placebo.
Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥500 cells/mm3 Adults.
|
Cohort 2: V920
n=40 participants at risk
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
\>350 and \<500 cells/mm3 Adults.
|
Cohort 2: Placebo
n=10 participants at risk
Participants randomly assigned to receive placebo. Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
\>350 and \<500 cells/mm3 Adults.
|
Cohort 3: V920
n=41 participants at risk
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 and ≤350 cells/mm3 Adults.
|
Cohort 3: Placebo
n=9 participants at risk
Participants randomly assigned to receive placebo. Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 and ≤350 cells/mm3 Adults.
|
Cohort 4: V920
n=40 participants at risk
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 cells/mm3 Adolescents.
|
Cohort 4: Placebo
n=10 participants at risk
Participants randomly assigned to receive placebo. Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 cells/mm3 Adolescents.
|
Cohort 5: V920
n=40 participants at risk
Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
≥200 cells/mm3 Adults and adolescents.
|
Cohort 5: Placebo
n=10 participants at risk
Participants randomly assigned to receive placebo. Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.
≥200 cells/mm3 Adults and adolescents.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
5.0%
2/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
4/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
General disorders
Fatigue
|
15.0%
6/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
20.0%
2/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Infections and infestations
Malaria
|
12.5%
5/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
4/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
5.0%
2/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Infections and infestations
Nasopharyngitis
|
7.5%
3/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
5.0%
2/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
General disorders
Pain
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
5.0%
2/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
5.0%
2/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Infections and infestations
Influenza
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
2/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
11.1%
1/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
12.5%
5/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
7.5%
3/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.5%
3/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
5.0%
2/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
5.0%
2/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
4/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Nervous system disorders
Headache
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
7.5%
3/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
7.5%
3/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Vascular disorders
Diastolic Hypertension
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
9.8%
4/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
11.1%
1/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
5.0%
2/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
7.5%
3/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Infections and infestations
Sinobronchitis
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
9.8%
4/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
11.1%
1/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
7.5%
3/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
11.1%
1/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
11.1%
1/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
General disorders
Ill-defined Disorder
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
5.0%
2/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Infections and infestations
Otitis Medica Chronic
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
10.0%
1/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/41 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/9 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
5.0%
2/40 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
0.00%
0/10 • 365 days
Serious Adverse Events were monitored at every visit through Day 365. All-cause mortality reported are at 1-year post vaccination. SAEs reported in this section are at 1-year postvaccination. AEs reported in this section are at 42 days postvaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place