Trial Outcomes & Findings for A Study to Assess Safety, Tolerability, and Immunogenicity of Three Heterologus 2-dose Regimens of the Candidate Prophylactic Vaccines for Ebola in Healthy Adults (NCT NCT02416453)
NCT ID: NCT02416453
Last Updated: 2021-02-08
Results Overview
An adverse event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal product, it does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal product. Unsolicited adverse events were events which were reported by the participant voluntarily or obtained by means of interviewing the participant in a nondirected manner at study visits.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
423 participants
Primary outcome timeframe
Up to 42-day post dose 2 visit (Day 1 to Day 127)
Results posted on
2021-02-08
Participant Flow
A total of 423 participants were randomized (408 participants in Groups 1 to 3 and 15 participants in Group 4). Among them, 421 participants received at least one dose of study vaccines. Two participants were randomized but not vaccinated.
Participant milestones
| Measure |
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5\*10\^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
|
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 29.
|
Group 1: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 29.
|
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 2: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 57.
|
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 3: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 85.
|
Group 4: Ad26.ZEBOV
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp on Day 1.
|
Group 4: Placebo
Participants received IM injection of placebo Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
112
|
13
|
114
|
13
|
106
|
18
|
13
|
2
|
|
Overall Study
COMPLETED
|
7
|
7
|
9
|
97
|
12
|
98
|
11
|
94
|
13
|
13
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
1
|
15
|
1
|
16
|
2
|
12
|
5
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5\*10\^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
|
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 29.
|
Group 1: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 29.
|
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 2: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 57.
|
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 3: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 85.
|
Group 4: Ad26.ZEBOV
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp on Day 1.
|
Group 4: Placebo
Participants received IM injection of placebo Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
0
|
8
|
0
|
5
|
1
|
3
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
5
|
1
|
8
|
0
|
8
|
4
|
0
|
0
|
|
Overall Study
PARTICIPANT UNABLE TO ATTEND ANY FURTHER
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
PARTICIPANT HAS MOVED TO SINGAPORE
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Assess Safety, Tolerability, and Immunogenicity of Three Heterologus 2-dose Regimens of the Candidate Prophylactic Vaccines for Ebola in Healthy Adults
Baseline characteristics by cohort
| Measure |
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=10 Participants
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5\*10\^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
|
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=10 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
n=10 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=112 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 29.
|
Group 1: Pooled Cohorts II and III: Placebo
n=13 Participants
Participants received IM injection of placebo on Day 1 and Day 29.
|
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=114 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 2: Pooled Cohorts II and III: Placebo
n=13 Participants
Participants received IM injection of placebo on Day 1 and Day 57.
|
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
n=106 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 3: Pooled Cohorts II and III: Placebo
n=18 Participants
Participants received IM injection of placebo on Day 1 and Day 85.
|
Group 4: Ad26.ZEBOV
n=13 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp on Day 1.
|
Group 4: Placebo
n=2 Participants
Participants received IM injection of placebo Day 1.
|
Total
n=421 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
36 Participants
n=42 Participants
|
|
Age, Continuous
|
34.2 years
STANDARD_DEVIATION 12.95 • n=5 Participants
|
47.4 years
STANDARD_DEVIATION 16.53 • n=7 Participants
|
38.7 years
STANDARD_DEVIATION 13.99 • n=5 Participants
|
41 years
STANDARD_DEVIATION 15 • n=4 Participants
|
39.1 years
STANDARD_DEVIATION 13.9 • n=21 Participants
|
41 years
STANDARD_DEVIATION 14.02 • n=8 Participants
|
38.2 years
STANDARD_DEVIATION 13.66 • n=8 Participants
|
38.3 years
STANDARD_DEVIATION 14.34 • n=24 Participants
|
41.1 years
STANDARD_DEVIATION 15.11 • n=42 Participants
|
37.9 years
STANDARD_DEVIATION 11.37 • n=42 Participants
|
47 years
STANDARD_DEVIATION 4.24 • n=42 Participants
|
40 years
STANDARD_DEVIATION 14.32 • n=42 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
62 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
53 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
217 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
52 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
53 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
204 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
102 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
89 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
365 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
55 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
50 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
197 Participants
n=42 Participants
|
|
Region of Enrollment
United Kingdom
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
59 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
56 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
224 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to 42-day post dose 2 visit (Day 1 to Day 127)Population: Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
An adverse event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal product, it does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal product. Unsolicited adverse events were events which were reported by the participant voluntarily or obtained by means of interviewing the participant in a nondirected manner at study visits.
Outcome measures
| Measure |
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=10 Participants
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5\*10\^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
|
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=10 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
n=10 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=112 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 29.
|
Group 1: Pooled Cohorts II and III: Placebo
n=13 Participants
Participants received IM injection of placebo on Day 1 and Day 29.
|
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=114 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 2: Pooled Cohorts II and III: Placebo
n=13 Participants
Participants received IM injection of placebo on Day 1 and Day 57.
|
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
n=106 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 3: Pooled Cohorts II and III: Placebo
n=18 Participants
Participants received IM injection of placebo on Day 1 and Day 85.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events (Groups 1, 2 and 3)
|
4 Participants
|
6 Participants
|
6 Participants
|
62 Participants
|
6 Participants
|
52 Participants
|
7 Participants
|
46 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Up to Day 365Population: Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=10 Participants
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5\*10\^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
|
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=10 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
n=10 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=112 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 29.
|
Group 1: Pooled Cohorts II and III: Placebo
n=13 Participants
Participants received IM injection of placebo on Day 1 and Day 29.
|
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=114 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 2: Pooled Cohorts II and III: Placebo
n=13 Participants
Participants received IM injection of placebo on Day 1 and Day 57.
|
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
n=106 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 3: Pooled Cohorts II and III: Placebo
n=18 Participants
Participants received IM injection of placebo on Day 1 and Day 85.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (Groups 1, 2 and 3)
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to Day 365Population: Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
The following neuroinflammatory disorders were considered immediate reportable events and which had to be reported to the sponsor within 24 hours of becoming aware of the event. Neuroinflammatory disorders included: cranial nerve disorders including paralyses/paresis (example: bell's palsy), optic neuritis, multiple sclerosis, transverse myelitis, guillain-barre syndrome including miller fisher syndrome, bickerstaff's encephalitis and other variants, acute disseminated encephalomyelitis, including site-specific variants (example: non-infectious encephalitis, encephalomyelitis, myelitis, myeloradiculomyelitis), myasthenia gravis and lambert-eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, including chronic inflammatory, demyelinating polyneuropathy, multifocal motor neuropathy, and polyneuropathies associated with monoclonal gammopathy, narcolepsy, isolated paresthesia of more than 7 days duration.
Outcome measures
| Measure |
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=10 Participants
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5\*10\^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
|
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=10 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
n=10 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=112 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 29.
|
Group 1: Pooled Cohorts II and III: Placebo
n=13 Participants
Participants received IM injection of placebo on Day 1 and Day 29.
|
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=114 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 2: Pooled Cohorts II and III: Placebo
n=13 Participants
Participants received IM injection of placebo on Day 1 and Day 57.
|
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
n=106 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 3: Pooled Cohorts II and III: Placebo
n=18 Participants
Participants received IM injection of placebo on Day 1 and Day 85.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Immediate Reportable Events (Groups 1, 2 and 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 7 days post-dose 1 (Day 8)Population: Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post first vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Outcome measures
| Measure |
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=10 Participants
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5\*10\^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
|
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=10 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
n=10 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=112 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 29.
|
Group 1: Pooled Cohorts II and III: Placebo
n=13 Participants
Participants received IM injection of placebo on Day 1 and Day 29.
|
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=114 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 2: Pooled Cohorts II and III: Placebo
n=13 Participants
Participants received IM injection of placebo on Day 1 and Day 57.
|
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
n=106 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 3: Pooled Cohorts II and III: Placebo
n=18 Participants
Participants received IM injection of placebo on Day 1 and Day 85.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local Adverse Events (Groups 1, 2 and 3)
|
8 Participants
|
6 Participants
|
8 Participants
|
63 Participants
|
3 Participants
|
65 Participants
|
2 Participants
|
78 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 7 days post-dose 2 (Up to Day 92)Population: Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post first vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Outcome measures
| Measure |
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=8 Participants
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5\*10\^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
|
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=9 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
n=9 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=91 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 29.
|
Group 1: Pooled Cohorts II and III: Placebo
n=10 Participants
Participants received IM injection of placebo on Day 1 and Day 29.
|
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=83 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 2: Pooled Cohorts II and III: Placebo
n=7 Participants
Participants received IM injection of placebo on Day 1 and Day 57.
|
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
n=62 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 3: Pooled Cohorts II and III: Placebo
n=11 Participants
Participants received IM injection of placebo on Day 1 and Day 85.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local Adverse Events (Groups 1, 2 and 3)
|
4 Participants
|
5 Participants
|
8 Participants
|
46 Participants
|
2 Participants
|
49 Participants
|
0 Participants
|
41 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 7 days post-dose 1 (Day 8)Population: Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Outcome measures
| Measure |
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=10 Participants
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5\*10\^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
|
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=10 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
n=10 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=112 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 29.
|
Group 1: Pooled Cohorts II and III: Placebo
n=13 Participants
Participants received IM injection of placebo on Day 1 and Day 29.
|
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=114 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 2: Pooled Cohorts II and III: Placebo
n=13 Participants
Participants received IM injection of placebo on Day 1 and Day 57.
|
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
n=106 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 3: Pooled Cohorts II and III: Placebo
n=18 Participants
Participants received IM injection of placebo on Day 1 and Day 85.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Adverse Events (Groups 1, 2 and 3)
|
8 Participants
|
10 Participants
|
10 Participants
|
89 Participants
|
7 Participants
|
84 Participants
|
8 Participants
|
82 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 7 days post-dose 2 (Up to Day 92)Population: Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Outcome measures
| Measure |
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=8 Participants
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5\*10\^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
|
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=9 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
n=9 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=91 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 29.
|
Group 1: Pooled Cohorts II and III: Placebo
n=10 Participants
Participants received IM injection of placebo on Day 1 and Day 29.
|
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=83 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 2: Pooled Cohorts II and III: Placebo
n=7 Participants
Participants received IM injection of placebo on Day 1 and Day 57.
|
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
n=62 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 3: Pooled Cohorts II and III: Placebo
n=11 Participants
Participants received IM injection of placebo on Day 1 and Day 85.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Adverse Events (Groups 1, 2 and 3)
|
6 Participants
|
5 Participants
|
5 Participants
|
42 Participants
|
5 Participants
|
36 Participants
|
2 Participants
|
38 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 28-day post dose 1 (Day 29)Population: Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
An AE is any untoward medical occurrence in a clinical study subject administered a medicinal product, it does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal product. Unsolicited adverse events were events which were reported by the participant voluntarily or obtained by means of interviewing the participant in a nondirected manner at study visits.
Outcome measures
| Measure |
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=13 Participants
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5\*10\^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
|
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=2 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 29.
|
Group 1: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 29.
|
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 2: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 57.
|
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 3: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 85.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events (Group 4)
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 180Population: Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=13 Participants
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5\*10\^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
|
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=2 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 29.
|
Group 1: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 29.
|
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 2: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 57.
|
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 3: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 85.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (Group 4)
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 180Population: Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
The following neuroinflammatory disorders were considered immediate reportable events which had to be reported to the sponsor within 24 hours of becoming aware of the event. Neuroinflammatory disorders included: cranial nerve disorders including paralyses/paresis (example: bell's palsy), optic neuritis, multiple sclerosis, transverse myelitis, guillain-barre syndrome including miller fisher syndrome, bickerstaff's encephalitis and other variants, acute disseminated encephalomyelitis, including site-specific variants (example: non-infectious encephalitis, encephalomyelitis, myelitis, myeloradiculomyelitis), myasthenia gravis and lambert-eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, including chronic inflammatory, demyelinating polyneuropathy, multifocal motor neuropathy, and polyneuropathies associated with monoclonal gammopathy, narcolepsy, isolated paresthesia of more than 7 days duration.
Outcome measures
| Measure |
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=13 Participants
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5\*10\^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
|
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=2 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 29.
|
Group 1: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 29.
|
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 2: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 57.
|
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 3: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 85.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Immediate Reportable Events (Group 4)
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 days after each vaccination (Up to Day 8)Population: Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post first vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Outcome measures
| Measure |
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=13 Participants
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5\*10\^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
|
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=2 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 29.
|
Group 1: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 29.
|
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 2: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 57.
|
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 3: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 85.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local Adverse Events (Group 4)
|
8 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 days after each vaccination (Up to Day 8)Population: Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Outcome measures
| Measure |
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=13 Participants
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5\*10\^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
|
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=2 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 29.
|
Group 1: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 29.
|
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 2: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 57.
|
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 3: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 85.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Adverse Events (Group 4)
|
11 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 21-days post dose 2 (Day 50 for Group 1; Day 78 for Group 2; and Day 106 for Group 3)Population: The per protocol analysis set included all randomized and vaccinated participants, who received both the prime and boost vaccinations (administered within the protocol-defined window), have at least 1 post-vaccination (that is, after the date of vaccination) evaluable immunogenicity sample, and have no major protocol violations influencing the immune response. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
GMCs of antibodies binding to EBOV GP using FANG ELISA were reported and were measured in ELISA unit per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using FANG ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the lower limit of quantification (LLOQ) (36.11 ELISA units/mL). The outcome measure was planned to be reported at 21-day post dose 2. Therefore, the results are reported for Group 1, 2 and 3 only.
Outcome measures
| Measure |
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=77 Participants
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5\*10\^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
|
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=7 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
n=69 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=7 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 29.
|
Group 1: Pooled Cohorts II and III: Placebo
n=48 Participants
Participants received IM injection of placebo on Day 1 and Day 29.
|
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=6 Participants
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 2: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 57.
|
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 3: Pooled Cohorts II and III: Placebo
Participants received IM injection of placebo on Day 1 and Day 85.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Filovirus Animal Non-Clinical Group (FANG) Enzyme-linked Immunosorbent Assay (ELISA) (Groups 1, 2 and 3)
|
4627 EU/mL
Interval 3649.0 to 5867.0
|
NA EU/mL
Interval to 55.0
Here, 'NA' signifies that Geometric mean and lower limit of 95% CI were not calculated because post dose values were less than LLOQ (36.11 ELISA units/mL).
|
10131 EU/mL
Interval 8554.0 to 11999.0
|
NA EU/mL
Here, 'NA' signifies that Geometric mean and CI were not calculated because post dose values were less than LLOQ (36.11 ELISA units/mL).
|
11312 EU/mL
Interval 9072.0 to 14106.0
|
NA EU/mL
Here, 'NA' signifies that Geometric mean and CI were not calculated because post dose values were less than LLOQ (36.11 ELISA units/mL).
|
—
|
—
|
—
|
Adverse Events
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
Serious events: 2 serious events
Other events: 41 other events
Deaths: 0 deaths
Group 1: Pooled Cohorts II and III: Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Group 2: Pooled Cohorts II and III: Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
Serious events: 5 serious events
Other events: 26 other events
Deaths: 0 deaths
Group 3: Pooled Cohorts II and III: Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 4: Ad26.ZEBOV
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 4: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=10 participants at risk
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5\*10\^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
|
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=10 participants at risk
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
n=10 participants at risk
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=112 participants at risk
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 29.
|
Group 1: Pooled Cohorts II and III: Placebo
n=13 participants at risk
Participants received IM injection of placebo on Day 1 and Day 29.
|
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=114 participants at risk
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 2: Pooled Cohorts II and III: Placebo
n=13 participants at risk
Participants received IM injection of placebo on Day 1 and Day 57.
|
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
n=106 participants at risk
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 3: Pooled Cohorts II and III: Placebo
n=18 participants at risk
Participants received IM injection of placebo on Day 1 and Day 85.
|
Group 4: Ad26.ZEBOV
n=13 participants at risk
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp on Day 1.
|
Group 4: Placebo
n=2 participants at risk
Participants received IM injection of placebo Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.94%
1/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Immune system disorders
Food allergy
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.94%
1/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.94%
1/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.89%
1/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.88%
1/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Investigations
Human papilloma virus test positive
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.89%
1/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteosarcoma
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
5.6%
1/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Nervous system disorders
Cerebral venous thrombosis
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.94%
1/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Nervous system disorders
Miller Fisher syndrome
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.88%
1/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Nervous system disorders
Small fibre neuropathy
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.88%
1/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.94%
1/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Surgical and medical procedures
Appendicectomy
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.88%
1/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
Other adverse events
| Measure |
Group 1: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=10 participants at risk
Participants received intramuscular (IM) injection of Ad26.ZEBOV at 5\*10\^10 viral particles (vp) as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 infectious units (Inf.U) (nominal titer) as dose 2 on Day 29.
|
Group 2: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=10 participants at risk
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 3: Cohort I: Ad26.ZEBOV, MVA-BN-Filo (84-Day Interval)
n=10 participants at risk
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 1: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (28-Day Interval)
n=112 participants at risk
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 29.
|
Group 1: Pooled Cohorts II and III: Placebo
n=13 participants at risk
Participants received IM injection of placebo on Day 1 and Day 29.
|
Group 2: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo (56-Day Interval)
n=114 participants at risk
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 57.
|
Group 2: Pooled Cohorts II and III: Placebo
n=13 participants at risk
Participants received IM injection of placebo on Day 1 and Day 57.
|
Group 3: Pooled Cohorts II and III: Ad26.ZEBOV, MVA-BN-Filo, (84-Day Interval)
n=106 participants at risk
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp as dose 1 on Day 1 followed by IM injection of MVA-BN-filo at 1\*10\^8 Inf.U (nominal titer) as dose 2 on Day 85.
|
Group 3: Pooled Cohorts II and III: Placebo
n=18 participants at risk
Participants received IM injection of placebo on Day 1 and Day 85.
|
Group 4: Ad26.ZEBOV
n=13 participants at risk
Participants received IM injection of Ad26.ZEBOV at 5\*10\^10 vp on Day 1.
|
Group 4: Placebo
n=2 participants at risk
Participants received IM injection of placebo Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
1.8%
2/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.88%
1/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Gastrointestinal disorders
Dental discomfort
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.88%
1/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.88%
1/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.94%
1/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
5.6%
1/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
20.0%
2/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
1.8%
2/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
5.6%
1/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.94%
1/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
5.6%
1/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
General disorders
Application site bruise
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
5.6%
1/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
General disorders
Asthenia
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.88%
1/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
5.6%
1/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
General disorders
Influenza like illness
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
1.8%
2/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
1.8%
2/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
General disorders
Injection site erythema
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.89%
1/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
General disorders
Injection site pain
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
General disorders
Pyrexia
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
5.6%
1/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
2.7%
3/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.94%
1/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
1.8%
2/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
5.6%
1/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Rhinitis
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
6.2%
7/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
5.3%
6/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
2.8%
3/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.88%
1/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
5.4%
6/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
5.3%
6/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
2.8%
3/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
5.6%
1/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.89%
1/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.89%
1/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.88%
1/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
2.8%
3/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
2.6%
3/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
2.8%
3/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.89%
1/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Investigations
Neutrophil count decreased
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
20.0%
2/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
2.7%
3/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
1.8%
2/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
1.9%
2/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
5.6%
1/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.89%
1/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.88%
1/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.89%
1/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.88%
1/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
5.6%
1/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
2.7%
3/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.88%
1/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
2.8%
3/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
15.4%
2/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
50.0%
1/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.89%
1/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.88%
1/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.89%
1/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.94%
1/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.94%
1/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
5.6%
1/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
2.7%
3/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
2.6%
3/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
4.7%
5/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
1.8%
2/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
1.8%
2/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
7.7%
1/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
3.6%
4/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.88%
1/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
15.4%
2/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
2.8%
3/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
5.6%
1/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.89%
1/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
10.0%
1/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/10 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/112 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/114 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/106 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/18 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/13 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
0.00%
0/2 • Up to Day 365
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo), regardless of the occurrence of protocol deviations.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER