Trial Outcomes & Findings for Safety, Tolerability and Immunogenicity Study of 3 Prime-boost Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo in Healthy Adults, Children and Human Immunodeficiency Virus Positive (HIV+) Adults (NCT NCT02564523)
NCT ID: NCT02564523
Last Updated: 2022-03-07
Results Overview
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1075 participants
Primary outcome timeframe
Up to 28 days post-dose 1 (Day 29)
Results posted on
2022-03-07
Participant Flow
A total of 1075 participants were enrolled. Among 1075 participants, 1 participant was enrolled twice and 1 participant was enrolled erroneously, but did not receive any study vaccination.
Participant milestones
| Measure |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
225
|
43
|
224
|
44
|
110
|
22
|
59
|
12
|
59
|
12
|
55
|
11
|
55
|
10
|
54
|
12
|
54
|
12
|
|
Overall Study
Participants Who Received Booster Dose at 1 Year Post Dose 1 (on Day 365)
|
34
|
8
|
39
|
9
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
215
|
40
|
214
|
43
|
106
|
22
|
56
|
12
|
59
|
12
|
52
|
10
|
53
|
10
|
54
|
12
|
54
|
11
|
|
Overall Study
NOT COMPLETED
|
10
|
3
|
10
|
1
|
4
|
0
|
3
|
0
|
0
|
0
|
3
|
1
|
2
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
4
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
2
|
2
|
5
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
3
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability and Immunogenicity Study of 3 Prime-boost Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo in Healthy Adults, Children and Human Immunodeficiency Virus Positive (HIV+) Adults
Baseline characteristics by cohort
| Measure |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
n=225 Participants
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
n=43 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
n=224 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
n=44 Participants
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
n=110 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
n=22 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=59 Participants
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
n=12 Participants
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=59 Participants
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
n=12 Participants
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=55 Participants
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
n=11 Participants
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=55 Participants
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
n=10 Participants
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=54 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
n=12 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=54 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
n=12 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Total
n=1073 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Region of Enrollment
UGANDA
|
83 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
22 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
13 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
12 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
14 Participants
n=136 Participants
|
4 Participants
n=44 Participants
|
368 Participants
n=667 Participants
|
|
Age, Continuous
|
33.3 years
STANDARD_DEVIATION 12.41 • n=5 Participants
|
32 years
STANDARD_DEVIATION 10.43 • n=7 Participants
|
33.3 years
STANDARD_DEVIATION 11.52 • n=5 Participants
|
33.3 years
STANDARD_DEVIATION 11.57 • n=4 Participants
|
31.4 years
STANDARD_DEVIATION 11.53 • n=21 Participants
|
33.7 years
STANDARD_DEVIATION 12.31 • n=8 Participants
|
38.8 years
STANDARD_DEVIATION 6.61 • n=8 Participants
|
34.3 years
STANDARD_DEVIATION 7.66 • n=24 Participants
|
39 years
STANDARD_DEVIATION 6.69 • n=42 Participants
|
42.1 years
STANDARD_DEVIATION 4.96 • n=42 Participants
|
14.4 years
STANDARD_DEVIATION 1.76 • n=42 Participants
|
14.5 years
STANDARD_DEVIATION 1.86 • n=42 Participants
|
14.1 years
STANDARD_DEVIATION 1.56 • n=36 Participants
|
14.2 years
STANDARD_DEVIATION 1.81 • n=36 Participants
|
7.6 years
STANDARD_DEVIATION 2.06 • n=24 Participants
|
7.1 years
STANDARD_DEVIATION 2.07 • n=135 Participants
|
7.8 years
STANDARD_DEVIATION 2.23 • n=136 Participants
|
7.3 years
STANDARD_DEVIATION 2.09 • n=44 Participants
|
28.3 years
STANDARD_DEVIATION 14.07 • n=667 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
39 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
42 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
26 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
27 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
28 Participants
n=136 Participants
|
5 Participants
n=44 Participants
|
434 Participants
n=667 Participants
|
|
Sex: Female, Male
Male
|
152 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
83 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
17 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
30 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
29 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
27 Participants
n=24 Participants
|
7 Participants
n=135 Participants
|
26 Participants
n=136 Participants
|
7 Participants
n=44 Participants
|
639 Participants
n=667 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 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
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
9 Participants
n=667 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
222 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
59 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
59 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
55 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
55 Participants
n=36 Participants
|
10 Participants
n=36 Participants
|
53 Participants
n=24 Participants
|
12 Participants
n=135 Participants
|
53 Participants
n=136 Participants
|
12 Participants
n=44 Participants
|
1063 Participants
n=667 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
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
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 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
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
4 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Black or African American
|
223 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
109 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
59 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
59 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
55 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
55 Participants
n=36 Participants
|
10 Participants
n=36 Participants
|
54 Participants
n=24 Participants
|
12 Participants
n=135 Participants
|
54 Participants
n=136 Participants
|
12 Participants
n=44 Participants
|
1068 Participants
n=667 Participants
|
|
Race (NIH/OMB)
White
|
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
|
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
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Race (NIH/OMB)
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
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Region of Enrollment
BURKINA FASO
|
76 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
29 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
25 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
23 Participants
n=136 Participants
|
4 Participants
n=44 Participants
|
369 Participants
n=667 Participants
|
|
Region of Enrollment
COTE D'IVOIRE
|
38 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
12 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
12 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
178 Participants
n=667 Participants
|
|
Region of Enrollment
KENYA
|
28 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
13 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
5 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
5 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
158 Participants
n=667 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days 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).
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Outcome measures
| Measure |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
n=225 Participants
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
n=43 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
n=224 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
n=44 Participants
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
n=110 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
n=22 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=59 Participants
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
n=12 Participants
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=59 Participants
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
n=12 Participants
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=55 Participants
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
n=11 Participants
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=55 Participants
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
n=10 Participants
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=54 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
n=12 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=54 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
n=12 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (Day 29)
|
96 Participants
|
17 Participants
|
68 Participants
|
17 Participants
|
37 Participants
|
6 Participants
|
25 Participants
|
7 Participants
|
25 Participants
|
3 Participants
|
28 Participants
|
4 Participants
|
31 Participants
|
5 Participants
|
23 Participants
|
4 Participants
|
19 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days post-dose 2 (Day 57 for Cohorts 1, 2a, 2b and 3 [28-Day Interval])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). Here, 'N' (number of participants analyzed) signifies those participants who were 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.
Outcome measures
| Measure |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
n=219 Participants
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
n=39 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
n=58 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
n=12 Participants
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
n=55 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
n=10 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=54 Participants
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
n=12 Participants
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) (28-Day Interval)
|
74 Participants
|
15 Participants
|
22 Participants
|
4 Participants
|
18 Participants
|
4 Participants
|
20 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up 28 days post-dose 2 (Day 85 for Cohorts 1, 2a, 2b and 3 [56-Day Interval])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). Here, 'N' (number of participants analyzed) signifies those participants who were 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.
Outcome measures
| Measure |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
n=200 Participants
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
n=39 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
n=59 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
n=12 Participants
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
n=54 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
n=10 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=54 Participants
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
n=11 Participants
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (56-day Interval)
|
58 Participants
|
13 Participants
|
22 Participants
|
4 Participants
|
26 Participants
|
4 Participants
|
22 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 28 days post-dose 2 (Day 113 for Cohort 1 [84-Day Interval])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). Here, 'N' (number of participants analyzed) signifies those participants who were 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.
Outcome measures
| Measure |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
n=98 Participants
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
n=21 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (84-day Interval)
|
34 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up 28 days post-dose 3 (Day 393)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).
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Outcome measures
| Measure |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
n=34 Participants
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
n=8 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
n=39 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
n=9 Participants
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events Post-dose 3 (Day 393)
|
9 Participants
|
3 Participants
|
14 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 3 years and 3 monthsPopulation: Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
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 |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
n=225 Participants
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
n=43 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
n=224 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
n=44 Participants
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
n=110 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
n=22 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=59 Participants
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
n=12 Participants
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=59 Participants
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
n=12 Participants
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=55 Participants
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
n=11 Participants
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=55 Participants
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
n=10 Participants
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=54 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
n=12 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=54 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
n=12 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events
|
7 Participants
|
1 Participants
|
7 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 3 years and 3 monthsPopulation: Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
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 |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
n=225 Participants
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
n=43 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
n=224 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
n=44 Participants
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
n=110 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
n=22 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=59 Participants
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
n=12 Participants
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=59 Participants
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
n=12 Participants
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=55 Participants
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
n=11 Participants
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=55 Participants
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
n=10 Participants
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=54 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
n=12 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=54 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
n=12 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Immediate Reportable Events (IREs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 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).
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 vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Outcome measures
| Measure |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
n=225 Participants
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
n=43 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
n=224 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
n=44 Participants
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
n=110 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
n=22 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=59 Participants
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
n=12 Participants
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=59 Participants
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
n=12 Participants
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=55 Participants
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
n=11 Participants
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=55 Participants
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
n=10 Participants
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=54 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
n=12 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=54 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
n=12 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local Adverse Events (Day 8)
|
123 Participants
|
16 Participants
|
121 Participants
|
20 Participants
|
63 Participants
|
11 Participants
|
34 Participants
|
4 Participants
|
35 Participants
|
2 Participants
|
26 Participants
|
3 Participants
|
30 Participants
|
5 Participants
|
26 Participants
|
6 Participants
|
29 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days post-dose 2 (Day 36 for Cohort 1, 2a, 2b and 3 [28-Day Interval])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). Here, 'N' (number of participants analyzed) signifies those participants who were 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 vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Outcome measures
| Measure |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
n=219 Participants
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
n=39 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
n=58 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
n=12 Participants
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
n=55 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
n=10 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=54 Participants
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
n=12 Participants
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local Adverse Events (28-day Interval)
|
126 Participants
|
9 Participants
|
26 Participants
|
2 Participants
|
29 Participants
|
3 Participants
|
22 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 7 days post-dose 2 (Day 64 for Cohort 1, 2a, 2b and 3 [56-Day Interval])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). Here, 'N' (number of participants analyzed) signifies those participants who were 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 vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Outcome measures
| Measure |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
n=200 Participants
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
n=39 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
n=59 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
n=12 Participants
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
n=54 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
n=10 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=54 Participants
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
n=11 Participants
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local Adverse Events Post-dose 2 (56-day Interval)
|
113 Participants
|
16 Participants
|
25 Participants
|
2 Participants
|
20 Participants
|
3 Participants
|
22 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 7 days post-dose 2 (Day 92 for Cohort 1 [84-Day Interval])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). Here, 'N' (number of participants analyzed) signifies those participants who were 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 vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Outcome measures
| Measure |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
n=98 Participants
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
n=21 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local Adverse Events (84-day Interval)
|
57 Participants
|
9 Participants
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
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—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up 7 days post-dose 3 (Day 372)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).
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 vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Outcome measures
| Measure |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
n=34 Participants
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
n=8 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
n=39 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
n=9 Participants
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local Adverse Events (Day 372)
|
18 Participants
|
1 Participants
|
16 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 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).
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 |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
n=225 Participants
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
n=43 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
n=224 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
n=44 Participants
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
n=110 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
n=22 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=59 Participants
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
n=12 Participants
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=59 Participants
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
n=12 Participants
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=55 Participants
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
n=11 Participants
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=55 Participants
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
n=10 Participants
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=54 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
n=12 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=54 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
n=12 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Adverse Events (Day 8)
|
146 Participants
|
27 Participants
|
140 Participants
|
26 Participants
|
75 Participants
|
14 Participants
|
44 Participants
|
7 Participants
|
36 Participants
|
2 Participants
|
29 Participants
|
4 Participants
|
30 Participants
|
5 Participants
|
24 Participants
|
2 Participants
|
23 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days post-dose 2 (Day 36 for Cohorts 1, 2a, 2b and 3 [28-Day Interval])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). Here, 'N' (number of participants analyzed) signifies those participants who were 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 |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
n=219 Participants
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
n=39 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
n=58 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
n=12 Participants
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
n=55 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
n=10 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=54 Participants
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
n=12 Participants
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Adverse Events (28-Day Interval)
|
121 Participants
|
14 Participants
|
32 Participants
|
4 Participants
|
27 Participants
|
3 Participants
|
10 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up 7 days post-dose 2 (Day 64 for Cohort 1, 2a, 2b and 3 [56-Day Interval])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). Here, 'N' (number of participants analyzed) signifies those participants who were 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 |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
n=200 Participants
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
n=39 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
n=59 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
n=12 Participants
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
n=54 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
n=10 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=54 Participants
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
n=11 Participants
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Adverse Events (56-Day Interval)
|
121 Participants
|
21 Participants
|
26 Participants
|
6 Participants
|
25 Participants
|
6 Participants
|
10 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up 7 days post-dose 2 (Day 92 for Cohort 1 [84-Day Interval])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). Here, 'N' (number of participants analyzed) signifies those participants who were 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 |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
n=98 Participants
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
n=21 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Adverse Events (84-Day Interval)
|
64 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 7 days post-dose 3 (Day 372)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).
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 |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
n=34 Participants
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
n=8 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
n=39 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
n=9 Participants
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Adverse Events (Day 372)
|
17 Participants
|
2 Participants
|
18 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 21-days post-dose 2 (Day 50 for Cohorts 1, 2a, 2b, 3 [28-day interval] , Day 78 for Cohort 1, 2a, 2b, 3 [56-day interval] and Day 106 Cohort 1 [84-day interval]Population: The per protocol analysis set included all randomized and vaccinated participants, who received both the prime and boost vaccinations (administered not more than 10 days outside the visit window), have immunogenicity data, from baseline and at least one post-vaccination evaluable immunogenicity sample, and have no major protocol violations influencing the immune response.
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).
Outcome measures
| Measure |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
n=225 Participants
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
n=43 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
n=224 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
n=44 Participants
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
n=110 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
n=22 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=59 Participants
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
n=12 Participants
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=59 Participants
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
n=12 Participants
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=55 Participants
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
n=11 Participants
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=55 Participants
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
n=10 Participants
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=54 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
n=12 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=54 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
n=12 Participants
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 50 (21 days post-dose 2)
|
3085 ELISA units/mL
Interval 2648.0 to 3594.0
|
NA ELISA units/mL
Here, "NA" signifies that the calculated Geometric mean and its 95% CI were less than LLOQ 36.11 ELISA units/mL).
|
—
|
—
|
—
|
—
|
4207 ELISA units/mL
Interval 3233.0 to 5474.0
|
NA ELISA units/mL
Interval to 39.0
Here, "NA" signifies that the calculated Geometric mean and its lower limit of 95% CI were less than LLOQ 36.11 ELISA units/mL).
|
—
|
—
|
6993 ELISA units/mL
Interval 5256.0 to 9303.0
|
NA ELISA units/mL
Interval to 74.0
Here, "NA" signifies that the calculated Geometric mean and its lower limit of 95% CI were less than LLOQ 36.11 ELISA units/mL).
|
—
|
—
|
8007 ELISA units/mL
Interval 6321.0 to 10142.0
|
NA ELISA units/mL
Interval to 82.0
Here, "NA" signifies that the calculated Geometric mean and its lower limit of 95% CI were less than LLOQ 36.11 ELISA units/mL).
|
—
|
—
|
|
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
Day 78 (21 days post-dose 2)
|
—
|
—
|
7518 ELISA units/mL
Interval 6468.0 to 8740.0
|
NA ELISA units/mL
Interval to 53.0
Here, "NA" signifies that the calculated Geometric mean and its lower limit of 95% CI were less than LLOQ 36.11 ELISA units/mL)
|
—
|
—
|
—
|
—
|
5283 ELISA units/mL
Interval 4094.0 to 6817.0
|
NA ELISA units/mL
Here, "NA" signifies that the calculated Geometric mean and its 95% CI were less than LLOQ 36.11 ELISA units/mL).
|
—
|
—
|
13532 ELISA units/mL
Interval 10732.0 to 17061.0
|
37 ELISA units/mL
Interval to 89.0
Here, "NA" signifies that the calculated Geometric mean and its lower limit of 95% CI were less than LLOQ 36.11 ELISA units/mL).
|
—
|
—
|
17388 ELISA units/mL
Interval 12973.0 to 23306.0
|
NA ELISA units/mL
Here, "NA" signifies that the calculated Geometric mean and its 95% CI were less than LLOQ 36.11 ELISA units/mL).
|
|
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
Day 106 (21 days post-dose 2)
|
—
|
—
|
—
|
—
|
7300 ELISA units/mL
Interval 5116.0 to 10417.0
|
NA ELISA units/mL
Here, "NA" signifies that the calculated Geometric mean and its 95% CI were less than LLOQ 36.11 ELISA units/mL).
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up 28 days post-dose 3 (Day 393)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).
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 |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
n=34 Participants
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
n=8 Participants
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
n=39 Participants
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
n=9 Participants
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events Post-dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
Serious events: 7 serious events
Other events: 94 other events
Deaths: 0 deaths
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
Serious events: 7 serious events
Other events: 80 other events
Deaths: 0 deaths
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
Serious events: 6 serious events
Other events: 43 other events
Deaths: 0 deaths
Cohort 1: Placebo, Placebo, 84-Day Interval
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Serious events: 1 serious events
Other events: 24 other events
Deaths: 1 deaths
Cohort 2a: Placebo, Placebo, 28-Day Interval
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Cohort 2a: Placebo, Placebo, 56-Day Interval
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Serious events: 1 serious events
Other events: 29 other events
Deaths: 1 deaths
Cohort 2b: Placebo, Placebo, 28-Day Interval
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Cohort 2b: Placebo, Placebo, 56-Day Interval
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Cohort 3: Placebo, Placebo, 28-Day Interval
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Cohort 3: Placebo, Placebo, 56-Day Interval
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
n=225 participants at risk
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
n=43 participants at risk
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
n=224 participants at risk
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
n=44 participants at risk
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
n=110 participants at risk
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
n=22 participants at risk
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=59 participants at risk
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
n=12 participants at risk
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=59 participants at risk
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
n=12 participants at risk
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=55 participants at risk
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
n=11 participants at risk
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=55 participants at risk
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
n=10 participants at risk
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=54 participants at risk
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
n=12 participants at risk
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=54 participants at risk
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
n=12 participants at risk
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Dolichocolon
|
0.44%
1/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Ear and labyrinth disorders
Meniere's Disease
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.3%
1/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Eye disorders
Cataract
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.45%
1/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Eye disorders
Glaucoma
|
0.44%
1/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.44%
1/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.45%
1/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.91%
1/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Gastrointestinal disorders
Obstruction Gastric
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.45%
1/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Infections and infestations
Cellulitis
|
0.44%
1/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Infections and infestations
Malaria
|
0.44%
1/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.3%
1/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.3%
3/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.7%
3/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.9%
1/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.91%
1/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Infections and infestations
Typhoid Fever
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Injury, poisoning and procedural complications
Alcohol Poisoning
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Injury, poisoning and procedural complications
Burns Second Degree
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.44%
1/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.45%
1/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.44%
1/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.45%
1/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Pregnancy, puerperium and perinatal conditions
Anembryonic Gestation
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.91%
1/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.45%
1/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
Other adverse events
| Measure |
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval
n=225 participants at risk
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5\*10\^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval
n=43 participants at risk
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval
n=224 participants at risk
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5\*10\^10 vp as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval
n=44 participants at risk
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
|
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval
n=110 participants at risk
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 85.
|
Cohort 1: Placebo, Placebo, 84-Day Interval
n=22 participants at risk
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=59 participants at risk
Participants (human immunodeficiency virus \[HIV\]-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2a: Placebo, Placebo, 28-Day Interval
n=12 participants at risk
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=59 participants at risk
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2a: Placebo, Placebo, 56-Day Interval
n=12 participants at risk
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=55 participants at risk
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 2b: Placebo, Placebo, 28-Day Interval
n=11 participants at risk
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=55 participants at risk
Participants ((Healthy Adolescents \[12-17 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 2b: Placebo, Placebo, 56-Day Interval
n=10 participants at risk
Participants (Healthy Adolescents \[12-17 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval
n=54 participants at risk
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 29.
|
Cohort 3: Placebo, Placebo, 28-Day Interval
n=12 participants at risk
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
|
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval
n=54 participants at risk
Participants (Healthy Children \[4-11 years\]) received IM injection of Ad26.ZEBOV 5\*10\^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U on Day 57.
|
Cohort 3: Placebo, Placebo, 56-Day Interval
n=12 participants at risk
Participants (Healthy Children \[4-11 years\]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Blepharitis
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
9.1%
1/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Eye disorders
Conjunctivitis Allergic
|
0.44%
1/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
9.1%
1/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
10.0%
1/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Cardiac disorders
Bradycardia
|
0.44%
1/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
10.0%
1/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Blood and lymphatic system disorders
Microcytic Anaemia
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
10.0%
1/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.2%
14/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.3%
1/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
3.6%
8/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
9.1%
4/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
2/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
9.1%
2/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
3.4%
2/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
16.7%
2/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
10.2%
6/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
3.6%
2/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
5.5%
3/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
10.0%
1/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.9%
1/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.9%
1/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.44%
1/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.45%
1/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
5.6%
3/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.9%
1/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.44%
1/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.3%
1/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
4/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.3%
1/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
5.1%
3/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
18.2%
2/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
3.7%
2/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.9%
1/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Eye disorders
Eye Pruritus
|
0.44%
1/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Gastrointestinal disorders
Dental Caries
|
0.89%
2/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.3%
1/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.89%
2/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.3%
1/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
4.5%
1/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
3/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.3%
3/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.3%
1/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.7%
3/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
4.5%
1/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
10.0%
1/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.9%
1/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.9%
1/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
General disorders
Chest Pain
|
0.44%
1/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.89%
2/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.3%
1/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
10.0%
1/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Infections and infestations
Bronchitis
|
1.3%
3/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
4.7%
2/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
4/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
7.4%
4/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
3.7%
2/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
16.7%
2/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Infections and infestations
Conjunctivitis
|
0.44%
1/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.89%
2/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.7%
3/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
5.5%
3/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Infections and infestations
Infection Parasitic
|
0.44%
1/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Infections and infestations
Influenza
|
0.89%
2/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.3%
1/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
4/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.3%
1/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
3.7%
2/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
5.6%
3/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Infections and infestations
Malaria
|
7.1%
16/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
4.7%
2/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
5.4%
12/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
11.4%
5/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
5.5%
6/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
9.1%
2/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
5.1%
3/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
5.5%
3/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
9.1%
1/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
14.5%
8/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
10.0%
1/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
13.0%
7/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
16.7%
2/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
7.4%
4/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Infections and infestations
Nasopharyngitis
|
3.6%
8/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
9.3%
4/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
4.9%
11/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.3%
1/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
2/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
4.5%
1/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
5.5%
3/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
7.3%
4/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
20.0%
2/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.9%
1/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
3.7%
2/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Infections and infestations
Pharyngitis
|
0.89%
2/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.91%
1/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.3%
1/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.45%
1/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Infections and infestations
Rhinitis
|
3.1%
7/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.89%
2/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.3%
1/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
3.6%
4/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
9.1%
2/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
3.4%
2/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
7.4%
4/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
11.1%
6/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Infections and infestations
Sepsis
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
3.4%
2/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Infections and infestations
Tonsillitis
|
1.3%
3/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.3%
1/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.9%
1/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
7.6%
17/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.3%
1/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.0%
18/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
6.8%
3/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.2%
9/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
13.6%
3/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
11.9%
7/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
5.1%
3/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
10.9%
6/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
5.5%
3/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
20.0%
2/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
7.4%
4/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
0.44%
1/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.91%
1/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.3%
1/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.45%
1/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.91%
1/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
6.8%
4/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.89%
2/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
4.7%
2/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.89%
2/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.91%
1/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
3.4%
2/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
9.1%
1/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.9%
1/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.9%
1/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Investigations
Blood Potassium Decreased
|
0.89%
2/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.3%
3/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
9.1%
1/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Investigations
Blood Sodium Decreased
|
4.0%
9/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
4/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
5.5%
3/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
10.0%
1/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Investigations
Blood Urea Decreased
|
1.3%
3/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.89%
2/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.91%
1/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
9.1%
5/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
10.0%
1/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.9%
1/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Investigations
Monocyte Count Decreased
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.91%
1/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Investigations
Neutrophil Count Decreased
|
0.44%
1/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.45%
1/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.3%
1/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
3.6%
2/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Investigations
Transaminases Increased
|
0.44%
1/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.45%
1/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.9%
1/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.91%
1/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
3.6%
2/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
9.1%
1/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
9.1%
5/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.89%
2/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
4.7%
2/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
2/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
4.5%
1/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
5.1%
3/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
10.9%
6/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
9.1%
1/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
12.7%
7/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
7.4%
4/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
5.6%
3/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.91%
1/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
3.4%
2/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
5.1%
3/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.9%
1/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.3%
3/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.3%
1/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.2%
5/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
6.8%
3/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.7%
3/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.5%
5/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
5/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.2%
5/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
2/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
5.1%
3/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Nervous system disorders
Headache
|
6.7%
15/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
9.3%
4/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
3.6%
8/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
6.8%
3/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
6.4%
7/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
9.1%
2/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
5.1%
3/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
3.4%
2/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
7.3%
4/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.9%
1/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.91%
1/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.3%
3/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
2.3%
1/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.45%
1/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
6.8%
3/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
2/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.7%
1/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.44%
1/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
4.7%
2/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
4/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.91%
1/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
3.4%
2/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
9.1%
1/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
10.0%
1/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
3.7%
2/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
25.0%
3/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
3.7%
2/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.45%
1/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
1.8%
1/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
5.6%
3/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/225 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/43 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/224 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/44 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/110 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/22 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
8.3%
1/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/59 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/11 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/55 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/10 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/54 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
0.00%
0/12 • Up to 3 years and 3 months
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
|
Additional Information
Executive Medical Director
Janssen Vaccines & Prevention B.V
Phone: 844-434-4210
Email: [email protected]
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.
- Publication restrictions are in place
Restriction type: OTHER