Trial Outcomes & Findings for A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN-Filo in Adult Participants (NCT NCT04228783)
NCT ID: NCT04228783
Last Updated: 2025-05-25
Results Overview
Antibody GMCs against the EBOV GP as measured by ELISA at 21 days post Vaccination 2 were reported. 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) of 36.11 EU/mL were imputed with half of the LLOQ prior to the computation of the GMCs.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
974 participants
Primary outcome timeframe
21 Days Post Vaccination 2 (Day 78)
Results posted on
2025-05-25
Participant Flow
A total of 974 participants were enrolled and randomized, of which 970 participants received the vaccination and were included in the analysis.
Participant milestones
| Measure |
Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1)
Participants received 0.5 milliliter (mL) intramuscular injection of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5\*10\^10 viral particles \[vp\], Lot A) on Day 1, followed by intramuscular injection of modified vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1\*10\^8 infectious units \[Inf U\], Lot 1) on Day 57.
|
Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot B) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 2) on Day 57.
|
Ad26.ZEBOV(Lot C), MVA-BN-Filo (Lot 3) (Group 3)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot C) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 3) on Day 57.
|
Placebo, Placebo (Group 4)
Participants received 0.5 mL intramuscular injection of placebo (0.9 percent \[%\] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
|
Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV (Group 5)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, a single Lot) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, a single Lot) on Day 57 and an intramuscular injection of booster dose of Ad26.ZEBOV (at a dose of 5\*10\^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
|
Placebo, Placebo, Placebo (Group 6)
Participants received 0.5 mL intramuscular injection of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57, and intramuscular injection of placebo matching to Ad26.ZEBOV booster on Day 177.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
287
|
288
|
287
|
48
|
50
|
10
|
|
Overall Study
COMPLETED
|
239
|
237
|
236
|
39
|
33
|
6
|
|
Overall Study
NOT COMPLETED
|
48
|
51
|
51
|
9
|
17
|
4
|
Reasons for withdrawal
| Measure |
Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1)
Participants received 0.5 milliliter (mL) intramuscular injection of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5\*10\^10 viral particles \[vp\], Lot A) on Day 1, followed by intramuscular injection of modified vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1\*10\^8 infectious units \[Inf U\], Lot 1) on Day 57.
|
Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot B) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 2) on Day 57.
|
Ad26.ZEBOV(Lot C), MVA-BN-Filo (Lot 3) (Group 3)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot C) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 3) on Day 57.
|
Placebo, Placebo (Group 4)
Participants received 0.5 mL intramuscular injection of placebo (0.9 percent \[%\] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
|
Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV (Group 5)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, a single Lot) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, a single Lot) on Day 57 and an intramuscular injection of booster dose of Ad26.ZEBOV (at a dose of 5\*10\^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
|
Placebo, Placebo, Placebo (Group 6)
Participants received 0.5 mL intramuscular injection of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57, and intramuscular injection of placebo matching to Ad26.ZEBOV booster on Day 177.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
0
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
36
|
36
|
28
|
6
|
14
|
3
|
|
Overall Study
Physician Decision
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
10
|
19
|
1
|
2
|
0
|
|
Overall Study
Other
|
4
|
3
|
2
|
1
|
0
|
0
|
Baseline Characteristics
A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN-Filo in Adult Participants
Baseline characteristics by cohort
| Measure |
Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1)
n=287 Participants
Participants received 0.5 milliliter (mL) intramuscular injection of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5\*10\^10 viral particles \[vp\], Lot A) on Day 1, followed by intramuscular injection of modified vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1\*10\^8 infectious units \[Inf U\], Lot 1) on Day 57.
|
Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2)
n=288 Participants
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot B) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 2) on Day 57.
|
Ad26.ZEBOV(Lot C), MVA-BN-Filo (Lot 3) (Group 3)
n=287 Participants
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot C) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 3) on Day 57.
|
Placebo, Placebo (Group 4)
n=48 Participants
Participants received 0.5 mL intramuscular injection of placebo (0.9 percent \[%\] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
|
Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV (Group 5)
n=50 Participants
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, a single Lot) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, a single Lot) on Day 57 and an intramuscular injection of booster dose of Ad26.ZEBOV (at a dose of 5\*10\^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
|
Placebo, Placebo, Placebo (Group 6)
n=10 Participants
Participants received 0.5 mL intramuscular injection of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57, and intramuscular injection of placebo matching to Ad26.ZEBOV booster on Day 177.
|
Total
n=970 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.3 years
STANDARD_DEVIATION 9.32 • n=99 Participants
|
34.7 years
STANDARD_DEVIATION 9.12 • n=107 Participants
|
35.3 years
STANDARD_DEVIATION 8.96 • n=206 Participants
|
35 years
STANDARD_DEVIATION 8.66 • n=7 Participants
|
32.5 years
STANDARD_DEVIATION 7.26 • n=31 Participants
|
35 years
STANDARD_DEVIATION 7.83 • n=30 Participants
|
35 years
STANDARD_DEVIATION 9.02 • n=3 Participants
|
|
Sex: Female, Male
Female
|
159 Participants
n=99 Participants
|
159 Participants
n=107 Participants
|
158 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
29 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
534 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
128 Participants
n=99 Participants
|
129 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
21 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
436 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
76 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
256 Participants
n=99 Participants
|
260 Participants
n=107 Participants
|
270 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
50 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
890 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
17 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
77 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
287 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
198 Participants
n=99 Participants
|
185 Participants
n=107 Participants
|
185 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
629 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
19 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
|
Region of Enrollment
UNITED STATES
|
287 Participants
n=99 Participants
|
288 Participants
n=107 Participants
|
287 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
50 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
970 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 21 Days Post Vaccination 2 (Day 78)Population: Per protocol (PP) analysis set included all randomized (Group 1-4 only) and vaccinated participants, who received Dose 1 and Dose 2 vaccinations, and booster vaccination (Groups 5 and 6 only) (administered within protocol-defined window), had at least 1 post vaccination (after date of vaccination) evaluable immunogenicity sample, had no major protocol deviations influencing the immune response. N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Antibody GMCs against the EBOV GP as measured by ELISA at 21 days post Vaccination 2 were reported. 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) of 36.11 EU/mL were imputed with half of the LLOQ prior to the computation of the GMCs.
Outcome measures
| Measure |
Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1)
n=163 Participants
Participants received 0.5 milliliter (mL) intramuscular injection of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5\*10\^10 viral particles \[vp\], Lot A) on Day 1, followed by intramuscular injection of modified vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1\*10\^8 infectious units \[Inf U\], Lot 1) on Day 57.
|
Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2)
n=163 Participants
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot B) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 2) on Day 57.
|
Ad26.ZEBOV(Lot C), MVA-BN-Filo (Lot 3) (Group 3)
n=149 Participants
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot C) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 3) on Day 57.
|
Placebo, Placebo (Group 4)
n=27 Participants
Participants received 0.5 mL intramuscular injection of placebo (0.9 percent \[%\] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
|
Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV (Group 5)
n=34 Participants
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, a single Lot) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, a single Lot) on Day 57 and an intramuscular injection of booster dose of Ad26.ZEBOV (at a dose of 5\*10\^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
|
Placebo, Placebo, Placebo (Group 6)
n=4 Participants
Participants received 0.5 mL intramuscular injection of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57, and intramuscular injection of placebo matching to Ad26.ZEBOV booster on Day 177.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against the Ebola Virus Glycoprotein (EBOV GP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 21 Days Post Vaccination 2
|
11077 EU/mL
Interval 9806.0 to 12514.0
|
12223 EU/mL
Interval 10665.0 to 14010.0
|
11818 EU/mL
Interval 10320.0 to 13534.0
|
NA EU/mL
Here, 'NA' signifies that geometric mean and lower and upper limit of 95% CI was less than LLOQ.
|
18877 EU/mL
Interval 14173.0 to 25142.0
|
NA EU/mL
Here, 'NA' signifies that geometric mean and lower and upper limit of 95% CI was less than LLOQ.
|
SECONDARY outcome
Timeframe: 56 Days Post Vaccination 1 (Day 57)Population: PP analysis set included all randomized (Groups 1-4 only) and vaccinated participants, who received Dose 1 and Dose 2 vaccinations, and booster vaccination (Groups 5 and 6 only) (administered within protocol-defined window), had at least 1 post vaccination (after date of vaccination) evaluable immunogenicity sample, had no major protocol deviations influence the immune response. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Antibody GMCs against the EBOV GP as measured by ELISA at 56 days post Vaccination 1 were reported. 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 LLOQ of 36.11 EU/mL were imputed with half of the LLOQ prior to the computation of the GMCs.
Outcome measures
| Measure |
Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1)
n=175 Participants
Participants received 0.5 milliliter (mL) intramuscular injection of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5\*10\^10 viral particles \[vp\], Lot A) on Day 1, followed by intramuscular injection of modified vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1\*10\^8 infectious units \[Inf U\], Lot 1) on Day 57.
|
Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2)
n=177 Participants
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot B) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 2) on Day 57.
|
Ad26.ZEBOV(Lot C), MVA-BN-Filo (Lot 3) (Group 3)
n=166 Participants
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot C) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 3) on Day 57.
|
Placebo, Placebo (Group 4)
n=29 Participants
Participants received 0.5 mL intramuscular injection of placebo (0.9 percent \[%\] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
|
Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV (Group 5)
n=39 Participants
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, a single Lot) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, a single Lot) on Day 57 and an intramuscular injection of booster dose of Ad26.ZEBOV (at a dose of 5\*10\^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
|
Placebo, Placebo, Placebo (Group 6)
n=6 Participants
Participants received 0.5 mL intramuscular injection of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57, and intramuscular injection of placebo matching to Ad26.ZEBOV booster on Day 177.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against the Ebola Virus Glycoprotein (EBOV GP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 56 Days Post Vaccination 1
|
988 EU/mL
Interval 842.0 to 1159.0
|
994 EU/mL
Interval 865.0 to 1142.0
|
960 EU/mL
Interval 819.0 to 1126.0
|
NA EU/mL
Here, 'NA' signifies that geometric mean and lower and upper limit of 95% CI was less than LLOQ.
|
1023 EU/mL
Interval 773.0 to 1354.0
|
NA EU/mL
Interval to 37.0
Here, 'NA' signifies that geometric mean and lower limit of 95% CI was less than LLOQ.
|
SECONDARY outcome
Timeframe: Until 7 Days after Vaccination 1 on Day 1 (Up to Day 8); Until 7 Days after Vaccination 2 on Day 57 (Up to Day 64)Population: Full analysis set (FAS) included all participants with at least one study vaccine administration documented. Here, "n (number analyzed)" signifies number of participants who were analyzed at the specified timepoints.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were injection site pain/tenderness, erythema, induration/swelling, itching, pruritis at the vaccination site.
Outcome measures
| Measure |
Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1)
n=287 Participants
Participants received 0.5 milliliter (mL) intramuscular injection of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5\*10\^10 viral particles \[vp\], Lot A) on Day 1, followed by intramuscular injection of modified vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1\*10\^8 infectious units \[Inf U\], Lot 1) on Day 57.
|
Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2)
n=288 Participants
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot B) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 2) on Day 57.
|
Ad26.ZEBOV(Lot C), MVA-BN-Filo (Lot 3) (Group 3)
n=287 Participants
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot C) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 3) on Day 57.
|
Placebo, Placebo (Group 4)
n=48 Participants
Participants received 0.5 mL intramuscular injection of placebo (0.9 percent \[%\] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
|
Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV (Group 5)
n=50 Participants
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, a single Lot) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, a single Lot) on Day 57 and an intramuscular injection of booster dose of Ad26.ZEBOV (at a dose of 5\*10\^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
|
Placebo, Placebo, Placebo (Group 6)
n=10 Participants
Participants received 0.5 mL intramuscular injection of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57, and intramuscular injection of placebo matching to Ad26.ZEBOV booster on Day 177.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination 1 and 2
Until 7 days after Vaccination 1
|
169 Participants
|
176 Participants
|
178 Participants
|
11 Participants
|
38 Participants
|
2 Participants
|
|
Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination 1 and 2
Until 7 days after Vaccination 2
|
95 Participants
|
107 Participants
|
106 Participants
|
11 Participants
|
21 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Until 7 Days after Vaccination 1 on Day 1 (Up to Day 8); Until 7 Days after Vaccination 2 on Day 57 (Up to Day 64)Population: FAS included all participants with at least one study vaccine administration documented. Here, "n (number analyzed)" signifies number of participants who were analyzed at the specified timepoints.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature greater than or equal to (\>=) 38.0 degree Celsius or \>=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post vaccination 1 and 2 (day of vaccination and the subsequent 7 days), if feasible, for the following events: fatigue, headache, nausea, myalgia, arthralgia, chills, and fever.
Outcome measures
| Measure |
Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1)
n=287 Participants
Participants received 0.5 milliliter (mL) intramuscular injection of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5\*10\^10 viral particles \[vp\], Lot A) on Day 1, followed by intramuscular injection of modified vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1\*10\^8 infectious units \[Inf U\], Lot 1) on Day 57.
|
Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2)
n=288 Participants
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot B) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 2) on Day 57.
|
Ad26.ZEBOV(Lot C), MVA-BN-Filo (Lot 3) (Group 3)
n=287 Participants
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot C) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 3) on Day 57.
|
Placebo, Placebo (Group 4)
n=48 Participants
Participants received 0.5 mL intramuscular injection of placebo (0.9 percent \[%\] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
|
Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV (Group 5)
n=50 Participants
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, a single Lot) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, a single Lot) on Day 57 and an intramuscular injection of booster dose of Ad26.ZEBOV (at a dose of 5\*10\^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
|
Placebo, Placebo, Placebo (Group 6)
n=10 Participants
Participants received 0.5 mL intramuscular injection of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57, and intramuscular injection of placebo matching to Ad26.ZEBOV booster on Day 177.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination 1 and 2
Until 7 days after Vaccination 1
|
162 Participants
|
144 Participants
|
156 Participants
|
18 Participants
|
37 Participants
|
2 Participants
|
|
Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination 1 and 2
Until 7 days after Vaccination 2
|
74 Participants
|
90 Participants
|
95 Participants
|
14 Participants
|
19 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Until 28 Days After Vaccination 1 on Day 1 (Up to Day 29); until 28 days after Vaccination 2 on Day 57 (Up to Day 85)Population: FAS included all participants with at least one study vaccine administration documented. Here, "n (number analyzed)" signifies number of participants who were analyzed at the specified timepoints.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.
Outcome measures
| Measure |
Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1)
n=287 Participants
Participants received 0.5 milliliter (mL) intramuscular injection of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5\*10\^10 viral particles \[vp\], Lot A) on Day 1, followed by intramuscular injection of modified vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1\*10\^8 infectious units \[Inf U\], Lot 1) on Day 57.
|
Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2)
n=288 Participants
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot B) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 2) on Day 57.
|
Ad26.ZEBOV(Lot C), MVA-BN-Filo (Lot 3) (Group 3)
n=287 Participants
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot C) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 3) on Day 57.
|
Placebo, Placebo (Group 4)
n=48 Participants
Participants received 0.5 mL intramuscular injection of placebo (0.9 percent \[%\] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
|
Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV (Group 5)
n=50 Participants
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, a single Lot) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, a single Lot) on Day 57 and an intramuscular injection of booster dose of Ad26.ZEBOV (at a dose of 5\*10\^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
|
Placebo, Placebo, Placebo (Group 6)
n=10 Participants
Participants received 0.5 mL intramuscular injection of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57, and intramuscular injection of placebo matching to Ad26.ZEBOV booster on Day 177.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events (AEs) Until 28 Days After Vaccination 1 and 2
Until 28 days after Vaccination 1
|
28 Participants
|
25 Participants
|
26 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) Until 28 Days After Vaccination 1 and 2
Until 28 days after Vaccination 2
|
14 Participants
|
8 Participants
|
17 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6Population: FAS included all participants with at least one study vaccine administration documented.
SAE was 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 |
Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1)
n=287 Participants
Participants received 0.5 milliliter (mL) intramuscular injection of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5\*10\^10 viral particles \[vp\], Lot A) on Day 1, followed by intramuscular injection of modified vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1\*10\^8 infectious units \[Inf U\], Lot 1) on Day 57.
|
Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2)
n=288 Participants
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot B) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 2) on Day 57.
|
Ad26.ZEBOV(Lot C), MVA-BN-Filo (Lot 3) (Group 3)
n=287 Participants
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot C) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 3) on Day 57.
|
Placebo, Placebo (Group 4)
n=48 Participants
Participants received 0.5 mL intramuscular injection of placebo (0.9 percent \[%\] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
|
Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV (Group 5)
n=50 Participants
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, a single Lot) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, a single Lot) on Day 57 and an intramuscular injection of booster dose of Ad26.ZEBOV (at a dose of 5\*10\^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
|
Placebo, Placebo, Placebo (Group 6)
n=10 Participants
Participants received 0.5 mL intramuscular injection of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57, and intramuscular injection of placebo matching to Ad26.ZEBOV booster on Day 177.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
4 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
Adverse Events
Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1)
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Ad26.ZEBOV(Lot C), MVA-BN-Filo (Lot 3) (Group 3)
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo, Placebo (Group 4)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV (Group 5)
Serious events: 3 serious events
Other events: 2 other events
Deaths: 1 deaths
Placebo, Placebo, Placebo (Group 6)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1)
n=287 participants at risk
Participants received 0.5 milliliter (mL) intramuscular injection of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5\*10\^10 viral particles \[vp\], Lot A) on Day 1, followed by intramuscular injection of modified vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1\*10\^8 infectious units \[Inf U\], Lot 1) on Day 57.
|
Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2)
n=288 participants at risk
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot B) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 2) on Day 57.
|
Ad26.ZEBOV(Lot C), MVA-BN-Filo (Lot 3) (Group 3)
n=287 participants at risk
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot C) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 3) on Day 57.
|
Placebo, Placebo (Group 4)
n=48 participants at risk
Participants received 0.5 mL intramuscular injection of placebo (0.9 percent \[%\] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
|
Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV (Group 5)
n=50 participants at risk
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, a single Lot) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, a single Lot) on Day 57 and an intramuscular injection of booster dose of Ad26.ZEBOV (at a dose of 5\*10\^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
|
Placebo, Placebo, Placebo (Group 6)
n=10 participants at risk
Participants received 0.5 mL intramuscular injection of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57, and intramuscular injection of placebo matching to Ad26.ZEBOV booster on Day 177.
|
|---|---|---|---|---|---|---|
|
General disorders
Chest Pain
|
0.35%
1/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/288 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/48 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/50 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/10 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.35%
1/288 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/48 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/50 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/10 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
|
Infections and infestations
Ophthalmic Herpes Zoster
|
0.35%
1/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/288 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/48 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/50 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/10 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/288 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/48 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
2.0%
1/50 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/10 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
|
Injury, poisoning and procedural complications
Fracture Displacement
|
0.35%
1/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/288 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/48 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/50 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/10 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
|
Injury, poisoning and procedural complications
Gun Shot Wound
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/288 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/48 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
2.0%
1/50 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/10 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
|
Injury, poisoning and procedural complications
Multiple Injuries
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/288 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.35%
1/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/48 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/50 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/10 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.35%
1/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/288 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/48 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/50 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/10 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/288 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.35%
1/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/48 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/50 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/10 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
|
Injury, poisoning and procedural complications
Stab Wound
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/288 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/48 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
2.0%
1/50 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/10 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.35%
1/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/288 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/48 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/50 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/10 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
|
Injury, poisoning and procedural complications
Venomous Bite
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/288 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.35%
1/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/48 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/50 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/10 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
|
Nervous system disorders
Alcoholic Seizure
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/288 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.35%
1/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/48 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/50 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/10 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/288 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
2.1%
1/48 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/50 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/10 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/288 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.35%
1/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/48 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/50 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
10.0%
1/10 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
|
Psychiatric disorders
Alcohol Withdrawal Syndrome
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/288 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.35%
1/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/48 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/50 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/10 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/288 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/48 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
2.0%
1/50 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/10 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
|
Vascular disorders
Accelerated Hypertension
|
0.35%
1/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/288 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/48 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/50 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/10 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/288 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.35%
1/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/48 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/50 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/10 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
Other adverse events
| Measure |
Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1)
n=287 participants at risk
Participants received 0.5 milliliter (mL) intramuscular injection of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5\*10\^10 viral particles \[vp\], Lot A) on Day 1, followed by intramuscular injection of modified vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1\*10\^8 infectious units \[Inf U\], Lot 1) on Day 57.
|
Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2)
n=288 participants at risk
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot B) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 2) on Day 57.
|
Ad26.ZEBOV(Lot C), MVA-BN-Filo (Lot 3) (Group 3)
n=287 participants at risk
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot C) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 3) on Day 57.
|
Placebo, Placebo (Group 4)
n=48 participants at risk
Participants received 0.5 mL intramuscular injection of placebo (0.9 percent \[%\] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
|
Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV (Group 5)
n=50 participants at risk
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, a single Lot) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, a single Lot) on Day 57 and an intramuscular injection of booster dose of Ad26.ZEBOV (at a dose of 5\*10\^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
|
Placebo, Placebo, Placebo (Group 6)
n=10 participants at risk
Participants received 0.5 mL intramuscular injection of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57, and intramuscular injection of placebo matching to Ad26.ZEBOV booster on Day 177.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Covid-19
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/288 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/48 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
4.0%
2/50 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
10.0%
1/10 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/288 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/287 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/48 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
0.00%
0/50 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
10.0%
1/10 • Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER