Trial Outcomes & Findings for Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo (NCT NCT02509494)
NCT ID: NCT02509494
Last Updated: 2022-07-18
Results Overview
Number of participants with solicited local AEs were reported. 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.
COMPLETED
PHASE3
1023 participants
7 days post dose 1 (Day 8)
2022-07-18
Participant Flow
Out of 1023 participants who signed informed consent form, only 1018 participants were randomized and received study treatment and were included in the analysis.
Participant milestones
| Measure |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
43
|
298
|
102
|
143
|
48
|
144
|
48
|
144
|
48
|
|
Overall Study
COMPLETED
|
28
|
217
|
64
|
132
|
43
|
133
|
45
|
137
|
46
|
|
Overall Study
NOT COMPLETED
|
15
|
81
|
38
|
11
|
5
|
11
|
3
|
7
|
2
|
Reasons for withdrawal
| Measure |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
47
|
19
|
6
|
3
|
3
|
1
|
3
|
1
|
|
Overall Study
Physician Decision
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
17
|
7
|
5
|
0
|
6
|
1
|
2
|
1
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Other
|
0
|
4
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Non-Compliance With Study Drug
|
1
|
11
|
7
|
0
|
1
|
2
|
1
|
1
|
0
|
Baseline Characteristics
Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo
Baseline characteristics by cohort
| Measure |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=43 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
n=298 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
n=102 Participants
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
n=143 Participants
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
n=48 Participants
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
n=144 Participants
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
n=48 Participants
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
n=144 Participants
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
n=48 Participants
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
Total
n=1018 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
26.9 years
STANDARD_DEVIATION 9.87 • n=5 Participants
|
27.5 years
STANDARD_DEVIATION 10.46 • n=7 Participants
|
29.6 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
14.2 years
STANDARD_DEVIATION 1.58 • n=4 Participants
|
14 years
STANDARD_DEVIATION 1.58 • n=21 Participants
|
7.7 years
STANDARD_DEVIATION 1.88 • n=10 Participants
|
7.9 years
STANDARD_DEVIATION 1.96 • n=115 Participants
|
1.9 years
STANDARD_DEVIATION 0.79 • n=6 Participants
|
1.9 years
STANDARD_DEVIATION 0.76 • n=6 Participants
|
16.6 years
STANDARD_DEVIATION 12.79 • n=64 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
73 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
67 Participants
n=6 Participants
|
21 Participants
n=6 Participants
|
350 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
248 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
71 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
77 Participants
n=6 Participants
|
27 Participants
n=6 Participants
|
668 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
298 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
143 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
144 Participants
n=10 Participants
|
48 Participants
n=115 Participants
|
144 Participants
n=6 Participants
|
48 Participants
n=6 Participants
|
1017 Participants
n=64 Participants
|
|
Ethnicity (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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Asian
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Black or African American
|
43 Participants
n=5 Participants
|
297 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
142 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
144 Participants
n=10 Participants
|
47 Participants
n=115 Participants
|
144 Participants
n=6 Participants
|
48 Participants
n=6 Participants
|
1014 Participants
n=64 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=64 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Region of Enrollment
SIERRA LEONE
|
43 Participants
n=5 Participants
|
298 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
143 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
144 Participants
n=10 Participants
|
48 Participants
n=115 Participants
|
144 Participants
n=6 Participants
|
48 Participants
n=6 Participants
|
1018 Participants
n=64 Participants
|
PRIMARY outcome
Timeframe: 7 days post dose 1 (Day 8)Population: The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
Number of participants with solicited local AEs were reported. 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 |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=43 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
n=298 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
n=102 Participants
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
n=143 Participants
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
n=48 Participants
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
n=144 Participants
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
n=48 Participants
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
n=144 Participants
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
n=48 Participants
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (Day 8)
|
12 Participants
|
51 Participants
|
17 Participants
|
14 Participants
|
3 Participants
|
30 Participants
|
2 Participants
|
21 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 7 days post dose 2 (Day 64)Population: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Number of participants with solicited local AEs were reported. 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 |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=43 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
n=246 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
n=86 Participants
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
n=142 Participants
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
n=46 Participants
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
n=143 Participants
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
n=48 Participants
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
n=143 Participants
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
n=48 Participants
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stages 1 and 2: Number of Participants With Solicited Local AEs (Day 64)
|
6 Participants
|
58 Participants
|
8 Participants
|
21 Participants
|
1 Participants
|
22 Participants
|
5 Participants
|
7 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 7 days post dose 3 (Day 738)Population: The FAS included all participants who received booster dose with Ad26.ZEBOV, regardless of the occurrence of protocol deviations. This outcome measure was only planned for participants who received booster vaccination with Ad26.ZEBOV hence other arms are not reported.
Number of participants with solicited local AEs were reported. 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 |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=29 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Solicited Local AEs (Day 738)
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 7 days post dose 1 (Day 8)Population: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included body temperature, vomiting, reduced activity, somnolence, fatigue, irritability/fussiness/crying/screaming, and loss of appetite (for preverbal children/infants) and body temperature, nausea/vomiting, fatigue/malaise, muscle pain, chills, joint pain and headache (for young children, adolescents, and adults).
Outcome measures
| Measure |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=43 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
n=298 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
n=102 Participants
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
n=143 Participants
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
n=48 Participants
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
n=144 Participants
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
n=48 Participants
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
n=144 Participants
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
n=48 Participants
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 8)
|
18 Participants
|
161 Participants
|
51 Participants
|
52 Participants
|
14 Participants
|
45 Participants
|
15 Participants
|
36 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: 7 days post dose 2 (Day 64)Population: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included body temperature, vomiting, reduced activity, somnolence, fatigue, irritability/fussiness/crying/screaming, and loss of appetite (for preverbal children/infants) and body temperature, nausea/vomiting, fatigue/malaise, muscle pain, chills, joint pain and headache (for young children, adolescents, and adults).
Outcome measures
| Measure |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=43 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
n=246 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
n=86 Participants
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
n=142 Participants
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
n=46 Participants
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
n=143 Participants
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
n=48 Participants
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
n=143 Participants
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
n=48 Participants
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 64)
|
17 Participants
|
107 Participants
|
39 Participants
|
26 Participants
|
6 Participants
|
27 Participants
|
8 Participants
|
23 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: 7 days post dose 3 (Up to Day 738)Population: The FAS included all participants who received booster dose with Ad26.ZEBOV, regardless of the occurrence of protocol deviations. This outcome measure was only planned for participants who received booster vaccination with Ad26.ZEBOV hence other arms are not reported.
Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included body temperature, vomiting, reduced activity, somnolence, fatigue, irritability/fussiness/crying/screaming, and loss of appetite (for preverbal children/infants) and body temperature, nausea/vomiting, fatigue/malaise, muscle pain, chills, joint pain and headache (for young children, adolescents, and adults).
Outcome measures
| Measure |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=29 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Solicited Systemic AEs (Day 738)
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 36 monthsPopulation: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
Number of Participants with SAEs were reported. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Outcome measures
| Measure |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=43 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stages 1: Number of Participants With Serious Adverse Events (SAEs)
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
Number of Participants with SAEs were reported. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Outcome measures
| Measure |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=298 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
n=102 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
n=143 Participants
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
n=48 Participants
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
n=144 Participants
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
n=48 Participants
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
n=144 Participants
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
n=48 Participants
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stages 2: Number of Participants With SAEs
|
16 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
15 Participants
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: 28 days post booster dose (Day 759)Population: The FAS included all participants who received booster dose with Ad26.ZEBOV, regardless of the occurrence of protocol deviations.
Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Outcome measures
| Measure |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=29 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Unsolicited AEs (Day 759)
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 28 days post dose 1 (Day 29)Population: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Outcome measures
| Measure |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=43 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Unsolicited AEs (Day 29)
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 28 days post dose 1 (Day 29)Population: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Outcome measures
| Measure |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=298 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
n=102 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
n=143 Participants
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
n=48 Participants
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
n=144 Participants
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
n=48 Participants
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
n=144 Participants
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
n=48 Participants
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Unsolicited AEs (Day 29)
|
198 Participants
|
65 Participants
|
54 Participants
|
20 Participants
|
60 Participants
|
18 Participants
|
88 Participants
|
28 Participants
|
—
|
PRIMARY outcome
Timeframe: 28 days post dose 2 (Day 85)Population: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Outcome measures
| Measure |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=43 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Unsolicited AEs (Day 85)
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 28 days post dose 2 (Day 85)Population: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Outcome measures
| Measure |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=246 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
n=86 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
n=142 Participants
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
n=46 Participants
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
n=143 Participants
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
n=48 Participants
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
n=143 Participants
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
n=48 Participants
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Unsolicited AEs (Day 85)
|
145 Participants
|
48 Participants
|
49 Participants
|
13 Participants
|
46 Participants
|
13 Participants
|
92 Participants
|
31 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 36 monthsPopulation: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
Number of participants with deaths were reported.
Outcome measures
| Measure |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=43 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Deaths
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
Number of participants (children and adolescents) with deaths were reported.
Outcome measures
| Measure |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=143 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
n=48 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
n=144 Participants
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
n=48 Participants
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
n=144 Participants
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
n=44 Participants
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Deaths (Children and Adolescents)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
Number of participants (adults) with deaths were reported.
Outcome measures
| Measure |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=298 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
n=102 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Deaths (Adults)
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 36 monthsPopulation: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
Number of participants with IREs were reported. The following list of neuroinflammatory disorders are categorized as IREs: Cranial nerve disorders, including paralyses/paresis, optic neuritis, multiple sclerosis, transverse myelitis, guillain-Barré syndrome, acute disseminated encephalomyelitis, including site specific variants, myasthenia gravis and Lambert-Eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, narcolepsy, isolated paresthesia of greater than (\>) 7 days duration.
Outcome measures
| Measure |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=43 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Immediate Reportable Event (IREs)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
Number of participants (children and adolescents) with IREs were reported. The following list of neuroinflammatory disorders are categorized as IREs: Cranial nerve disorders, including paralyses/paresis, optic neuritis, multiple sclerosis, transverse myelitis, guillain-Barré syndrome, acute disseminated encephalomyelitis, including site specific variants, myasthenia gravis and Lambert-Eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, narcolepsy, isolated paresthesia of greater than (\>) 7 days duration.
Outcome measures
| Measure |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=143 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
n=48 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
n=144 Participants
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
n=48 Participants
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
n=144 Participants
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
n=48 Participants
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With IREs (Children and Adolescents)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
Number of participants (adults) with IREs were reported. The following list of neuroinflammatory disorders are categorized as IREs: Cranial nerve disorders, including paralyses/paresis, optic neuritis, multiple sclerosis, transverse myelitis, guillain-Barré syndrome, acute disseminated encephalomyelitis, including site specific variants, myasthenia gravis and Lambert-Eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, narcolepsy, isolated paresthesia of greater than (\>) 7 days duration.
Outcome measures
| Measure |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=298 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
n=102 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With IREs (Adults)
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 21 days post-dose 2 (Day 78)Population: The per protocol analysis set included all randomized and vaccinated participants, who received both the prime and boost vaccinations had at least 1 post-vaccination evaluable immunogenicity sample, and had no major protocol violations influencing the immune response. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
GMCs of antibodies binding to EBOV GP using ELISA were reported and were measured in ELISA units per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using 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 |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=42 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
n=182 Participants
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
n=62 Participants
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
n=134 Participants
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
n=46 Participants
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
n=124 Participants
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
n=43 Participants
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
n=124 Participants
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
n=38 Participants
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Stages 1 and 2: Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Enzyme-linked Immunosorbent Assay (ELISA)
|
4784 ELISA units/mL
Interval 3736.0 to 6125.0
|
3810 ELISA units/mL
Interval 3312.0 to 4383.0
|
50 ELISA units/mL
Interval to 70.0
Here, 'NA' signifies that lower limit of calculated 95% CI was less than LLOQ.
|
9929 ELISA units/mL
Interval 8172.0 to 12064.0
|
74 ELISA units/mL
Interval 48.0 to 114.0
|
10212 ELISA units/mL
Interval 8419.0 to 12388.0
|
42 ELISA units/mL
Interval to 60.0
Here, 'NA' signifies that lower limit of calculated 95% CI was less than LLOQ.
|
22568 ELISA units/mL
Interval 18426.0 to 27642.0
|
NA ELISA units/mL
Interval to 38.0
Here, 'NA' signifies that geometric mean and lower limit of calculated 95% CI was less than LLOQ.
|
Adverse Events
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
Stage 2 (>=18 Years): MenACWY, Placebo
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
Stage 2 (12-17 Years): MenACWY, Placebo
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
Stage 2 (4-11 Years): MenACWY, Placebo
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
Stage 2 (1-3 Years): MenACWY, Placebo
Serious adverse events
| Measure |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=43 participants at risk
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
n=298 participants at risk
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
n=102 participants at risk
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
n=143 participants at risk
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
n=48 participants at risk
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
n=144 participants at risk
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
n=48 participants at risk
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
n=144 participants at risk
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
n=48 participants at risk
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.34%
1/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.69%
1/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.8%
4/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Blood and lymphatic system disorders
Anaemia of Pregnancy
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.34%
1/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.69%
1/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.1%
1/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Eye disorders
Retinal Detachment
|
2.3%
1/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.34%
1/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Gastrointestinal disorders
Peptic Ulcer
|
2.3%
1/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.67%
2/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Brain Abscess
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.34%
1/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.69%
1/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Chorioretinitis
|
2.3%
1/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.67%
2/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.9%
3/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.69%
1/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Helminthic Infection
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.34%
1/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Malaria
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
1.0%
3/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
1.4%
2/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
9.7%
14/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
4.2%
2/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Meningitis Bacterial
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.69%
1/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.1%
1/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Orchitis
|
2.3%
1/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Osteomyelitis Chronic
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.69%
1/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.69%
1/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.8%
4/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.69%
1/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.69%
1/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Sepsis
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.34%
1/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
4.2%
6/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Subcutaneous Abscess
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.34%
1/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.69%
1/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Typhoid Fever
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.1%
1/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Injury, poisoning and procedural complications
Abortion Induced Incomplete
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.34%
1/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Injury, poisoning and procedural complications
Chest Injury
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.34%
1/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.67%
2/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.34%
1/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Injury, poisoning and procedural complications
Multiple Injuries
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.34%
1/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Injury, poisoning and procedural complications
Open Globe Injury
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.34%
1/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.34%
1/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.34%
1/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.34%
1/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Nervous system disorders
Febrile Convulsion
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.69%
1/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Nervous system disorders
Syncope
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.98%
1/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Threatened
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.34%
1/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Pregnancy, puerperium and perinatal conditions
Haemorrhage in Pregnancy
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.34%
1/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Pregnancy, puerperium and perinatal conditions
Placenta Praevia
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.34%
1/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Pregnancy, puerperium and perinatal conditions
Premature Labour
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.34%
1/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Renal and urinary disorders
Renal Haematoma
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.98%
1/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.69%
1/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Vascular disorders
Hypovolaemic Shock
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.34%
1/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
Other adverse events
| Measure |
Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV)
n=43 participants at risk
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731).
|
Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo
n=298 participants at risk
Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (>=18 Years): MenACWY, Placebo
n=102 participants at risk
Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo
n=143 participants at risk
Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57.
|
Stage 2 (12-17 Years): MenACWY, Placebo
n=48 participants at risk
Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo
n=144 participants at risk
Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57.
|
Stage 2 (4-11 Years): MenACWY, Placebo
n=48 participants at risk
Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57.
|
Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo
n=144 participants at risk
Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented.
|
Stage 2 (1-3 Years): MenACWY, Placebo
n=48 participants at risk
Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
1/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.67%
2/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.70%
1/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
6.2%
3/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
4.2%
6/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
8.3%
4/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
9.0%
13/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.1%
1/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.67%
2/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.69%
1/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
5.6%
8/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
6.2%
3/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Gastrointestinal disorders
Peptic Ulcer
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
5.0%
15/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.98%
1/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.1%
1/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
General disorders
Pain
|
7.0%
3/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
5.4%
16/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
9.8%
10/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.1%
3/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.1%
1/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.1%
1/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Furuncle
|
14.0%
6/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
3.7%
11/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.9%
3/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
1.4%
2/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.1%
1/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.69%
1/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
4.2%
2/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
4.2%
6/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
6.2%
3/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Gastroenteritis
|
2.3%
1/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
3.4%
10/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.0%
2/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.70%
1/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.1%
3/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
4.2%
2/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
4.9%
7/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
10.4%
5/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Malaria
|
14.0%
6/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
41.3%
123/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
39.2%
40/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
24.5%
35/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
18.8%
9/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
34.7%
50/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
29.2%
14/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
56.2%
81/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
54.2%
26/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
7.0%
21/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
4.9%
5/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.70%
1/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
3.5%
5/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
4.2%
6/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
10.4%
5/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Respiratory Tract Infection
|
4.7%
2/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
5.0%
15/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
3.9%
4/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
4.2%
6/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
4.2%
2/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.8%
4/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
8.3%
4/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
11.8%
17/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
10.4%
5/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Tinea Capitis
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
1.4%
2/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.1%
1/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
1.4%
2/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
6.2%
3/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Typhoid Fever
|
2.3%
1/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
4.7%
14/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
8.8%
9/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.69%
1/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.3%
1/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
5.4%
16/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
7.8%
8/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.1%
3/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.1%
1/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
6.2%
9/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
8.3%
4/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
18.1%
26/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
18.8%
9/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.3%
7/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.0%
2/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
5.6%
8/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
10.4%
5/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.1%
3/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.1%
1/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.7%
2/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
5.4%
16/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
6.9%
7/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.70%
1/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Nervous system disorders
Headache
|
20.9%
9/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
13.4%
40/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
12.7%
13/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
9.8%
14/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
4.2%
2/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.8%
4/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalised
|
2.3%
1/43 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
5.0%
15/298 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
4.9%
5/102 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
2.1%
3/143 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.69%
1/144 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
|
Additional Information
Senior Director Clinical Franchise Lead
Janssen Vaccines & Prevention B.V.
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will with hold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER