Trial Outcomes & Findings for A Study of 2-dose Vaccination Regimen of Ad26.ZEBOV and MVA-BN-Filo in Infants (NCT NCT03929757)
NCT ID: NCT03929757
Last Updated: 2025-05-25
Results Overview
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site, were pre-defined local (at the injection site) AEs for which participant were specifically questioned and which were noted by participant in their diary for 7 days post vaccination. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
108 participants
Primary outcome timeframe
From dose 1 (Day 1) up to 7 days post-dose 1 (Day 8)
Results posted on
2025-05-25
Participant Flow
Participant milestones
| Measure |
Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY
Healthy participants (infants) aged 4-11 months, were administered with 0.5 milliliter (mL) of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine (5\*10\^10 viral particles \[vp\]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo; 1\*10\^8 infectious units \[Inf U\]) vaccine by IM injection on Day 57. Participants also received a dose of World Health Organisation (WHO)-prequalified 0.5 mL of Meningococcal Group A, C, W135, and Y conjugate (MenACWY) vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
Main Study: MenACWY (Control Arm)
Healthy participants were administered with 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants also received a dose of MenACWY vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
Extension Study: Ad26.ZEBOV + MVA-BN-Filo
Participants who were originally randomized to the control arm and who had not withdrawn during the main study entered the extension phase to receive 0.5 mL of Ad26.ZEBOV vaccine (5\*10\^10 vp) on Day 1 by IM injection followed by 0.5 mL of MVA-BN-Filo (1\*10\^8 Inf U) vaccine by IM injection on Day 57. Participants were also followed-up for safety until 28 days post-dose 2, that is, Day 85.
|
|---|---|---|---|
|
Main Study: Up to Day 365
STARTED
|
75
|
33
|
0
|
|
Main Study: Up to Day 365
COMPLETED
|
72
|
33
|
0
|
|
Main Study: Up to Day 365
NOT COMPLETED
|
3
|
0
|
0
|
|
Extension Study: Up to Extension Day 85
STARTED
|
0
|
0
|
26
|
|
Extension Study: Up to Extension Day 85
COMPLETED
|
0
|
0
|
25
|
|
Extension Study: Up to Extension Day 85
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY
Healthy participants (infants) aged 4-11 months, were administered with 0.5 milliliter (mL) of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine (5\*10\^10 viral particles \[vp\]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo; 1\*10\^8 infectious units \[Inf U\]) vaccine by IM injection on Day 57. Participants also received a dose of World Health Organisation (WHO)-prequalified 0.5 mL of Meningococcal Group A, C, W135, and Y conjugate (MenACWY) vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
Main Study: MenACWY (Control Arm)
Healthy participants were administered with 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants also received a dose of MenACWY vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
Extension Study: Ad26.ZEBOV + MVA-BN-Filo
Participants who were originally randomized to the control arm and who had not withdrawn during the main study entered the extension phase to receive 0.5 mL of Ad26.ZEBOV vaccine (5\*10\^10 vp) on Day 1 by IM injection followed by 0.5 mL of MVA-BN-Filo (1\*10\^8 Inf U) vaccine by IM injection on Day 57. Participants were also followed-up for safety until 28 days post-dose 2, that is, Day 85.
|
|---|---|---|---|
|
Main Study: Up to Day 365
Withdrawal by parent/guardian
|
2
|
0
|
0
|
|
Main Study: Up to Day 365
Other
|
1
|
0
|
0
|
|
Extension Study: Up to Extension Day 85
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
A Study of 2-dose Vaccination Regimen of Ad26.ZEBOV and MVA-BN-Filo in Infants
Baseline characteristics by cohort
| Measure |
Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY
n=75 Participants
Healthy participants (infants) aged 4-11 months, were administered with 0.5 milliliter (mL) of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine (5\*10\^10 viral particles \[vp\]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo; 1\*10\^8 infectious units \[Inf U\]) vaccine by IM injection on Day 57. Participants also received a dose of World Health Organisation (WHO)-prequalified 0.5 mL of Meningococcal Group A, C, W135, and Y conjugate (MenACWY) vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
Main Study: MenACWY (Control Arm)
n=33 Participants
Healthy participants were administered with 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants also received a dose of MenACWY vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.7 months
STANDARD_DEVIATION 2.51 • n=5 Participants
|
7.5 months
STANDARD_DEVIATION 2.66 • n=7 Participants
|
7.6 months
STANDARD_DEVIATION 2.55 • n=5 Participants
|
|
Age, Customized
4 to <= 8 months
|
43 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Age, Customized
>8 to 11 months
|
32 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
39 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
39 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Region of Enrollment
Guinea
|
39 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Region of Enrollment
Sierra Leone
|
36 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From dose 1 (Day 1) up to 7 days post-dose 1 (Day 8)Population: The full analysis set included all participants with at least one study intervention administration documented.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site, were pre-defined local (at the injection site) AEs for which participant were specifically questioned and which were noted by participant in their diary for 7 days post vaccination. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Outcome measures
| Measure |
Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY
n=75 Participants
Healthy participants (infants) aged 4-11 months, were administered with 0.5 milliliter (mL) of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine (5\*10\^10 viral particles \[vp\]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo; 1\*10\^8 infectious units \[Inf U\]) vaccine by IM injection on Day 57. Participants also received a dose of World Health Organisation (WHO)-prequalified 0.5 mL of Meningococcal Group A, C, W135, and Y conjugate (MenACWY) vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
Main Study: MenACWY (Control Arm)
n=33 Participants
Healthy participants were administered with 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants also received a dose of MenACWY vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
|---|---|---|
|
Main Study: Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) up to 7 Days Post-dose 1
Solicited Local AEs
|
14.7 Percentage of Participants
|
6.1 Percentage of Participants
|
|
Main Study: Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) up to 7 Days Post-dose 1
Solicited Systemic AEs
|
36.0 Percentage of Participants
|
30.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: From dose 2 (Day 57) up to 7 days post-dose 2 (Day 64)Population: The full analysis set included all participants with at least one study intervention administration documented.
An AE is any untoward medical occurrence in a participants participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site, were pre-defined local (at the injection site) AEs for which participant were specifically questioned and which were noted by participant in their diary for 7 days post vaccination. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Outcome measures
| Measure |
Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY
n=75 Participants
Healthy participants (infants) aged 4-11 months, were administered with 0.5 milliliter (mL) of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine (5\*10\^10 viral particles \[vp\]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo; 1\*10\^8 infectious units \[Inf U\]) vaccine by IM injection on Day 57. Participants also received a dose of World Health Organisation (WHO)-prequalified 0.5 mL of Meningococcal Group A, C, W135, and Y conjugate (MenACWY) vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
Main Study: MenACWY (Control Arm)
n=33 Participants
Healthy participants were administered with 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants also received a dose of MenACWY vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
|---|---|---|
|
Main Study: Percentage of Participants With Solicited Local and Systemic AEs up to 7 Days Post-dose 2
Solicited Local AEs
|
9.3 Percentage of Participants
|
9.1 Percentage of Participants
|
|
Main Study: Percentage of Participants With Solicited Local and Systemic AEs up to 7 Days Post-dose 2
Solicited Systemic AEs
|
29.3 Percentage of Participants
|
33.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: From dose 1 (Day 1) up to 28 days post-dose 1 (Day 29)Population: The full analysis set included all participants with at least one study intervention administration documented.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were events which were reported by the participant voluntarily or obtained by means of interviewing the participants in a nondirected manner.
Outcome measures
| Measure |
Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY
n=75 Participants
Healthy participants (infants) aged 4-11 months, were administered with 0.5 milliliter (mL) of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine (5\*10\^10 viral particles \[vp\]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo; 1\*10\^8 infectious units \[Inf U\]) vaccine by IM injection on Day 57. Participants also received a dose of World Health Organisation (WHO)-prequalified 0.5 mL of Meningococcal Group A, C, W135, and Y conjugate (MenACWY) vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
Main Study: MenACWY (Control Arm)
n=33 Participants
Healthy participants were administered with 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants also received a dose of MenACWY vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
|---|---|---|
|
Main Study: Percentage of Participants With Unsolicited AEs up to 28 Days Post-dose 1
|
61.3 Percentage of Participants
|
66.7 Percentage of Participants
|
PRIMARY outcome
Timeframe: From dose 2 (Day 57) up to 28 days post-dose 2 (Day 85)Population: The full analysis set included all participants with at least one study intervention administration documented.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were events which were reported by the participant voluntarily or obtained by means of interviewing the participant in a nondirected manner.
Outcome measures
| Measure |
Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY
n=75 Participants
Healthy participants (infants) aged 4-11 months, were administered with 0.5 milliliter (mL) of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine (5\*10\^10 viral particles \[vp\]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo; 1\*10\^8 infectious units \[Inf U\]) vaccine by IM injection on Day 57. Participants also received a dose of World Health Organisation (WHO)-prequalified 0.5 mL of Meningococcal Group A, C, W135, and Y conjugate (MenACWY) vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
Main Study: MenACWY (Control Arm)
n=33 Participants
Healthy participants were administered with 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants also received a dose of MenACWY vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
|---|---|---|
|
Main Study: Percentage of Participants With Unsolicited AEs up to 28 Days Post-dose 2
|
57.3 Percentage of Participants
|
72.7 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 6 months post dose-2 on Day 57 (Up to 8 months)Population: The full analysis set included all participants with at least one study intervention administration documented.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY
n=75 Participants
Healthy participants (infants) aged 4-11 months, were administered with 0.5 milliliter (mL) of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine (5\*10\^10 viral particles \[vp\]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo; 1\*10\^8 infectious units \[Inf U\]) vaccine by IM injection on Day 57. Participants also received a dose of World Health Organisation (WHO)-prequalified 0.5 mL of Meningococcal Group A, C, W135, and Y conjugate (MenACWY) vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
Main Study: MenACWY (Control Arm)
n=33 Participants
Healthy participants were administered with 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants also received a dose of MenACWY vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
|---|---|---|
|
Main Study: Percentage of Participants With Serious Adverse Events (SAEs) up to 6 Months Post Dose-2 on Day 57
|
13.3 Percentage of Participants
|
12.1 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to Day 365Population: The full analysis set included all participants with at least one study intervention administration documented.
Percentage of participants with SAEs related to study intervention were reported. A SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY
n=75 Participants
Healthy participants (infants) aged 4-11 months, were administered with 0.5 milliliter (mL) of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine (5\*10\^10 viral particles \[vp\]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo; 1\*10\^8 infectious units \[Inf U\]) vaccine by IM injection on Day 57. Participants also received a dose of World Health Organisation (WHO)-prequalified 0.5 mL of Meningococcal Group A, C, W135, and Y conjugate (MenACWY) vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
Main Study: MenACWY (Control Arm)
n=33 Participants
Healthy participants were administered with 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants also received a dose of MenACWY vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
|---|---|---|
|
Main Study: Percentage of Participants With SAEs Related to Study Intervention
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: 21 days post-dose 2 (Day 78)Population: The per-protocol immunogenicity population included all randomized and vaccinated participants for whom immunogenicity data were available excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes (for example, missed Dose 2 vaccination, natural infections, etc.).
Geometric mean of binding antibody levels against the EBOV GP were reported.
Outcome measures
| Measure |
Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY
n=74 Participants
Healthy participants (infants) aged 4-11 months, were administered with 0.5 milliliter (mL) of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine (5\*10\^10 viral particles \[vp\]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo; 1\*10\^8 infectious units \[Inf U\]) vaccine by IM injection on Day 57. Participants also received a dose of World Health Organisation (WHO)-prequalified 0.5 mL of Meningococcal Group A, C, W135, and Y conjugate (MenACWY) vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
Main Study: MenACWY (Control Arm)
n=33 Participants
Healthy participants were administered with 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants also received a dose of MenACWY vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
|---|---|---|
|
Main Study: Geometric Mean of Binding Antibody Levels Against the Ebola Virus Glycoprotein (EBOV GP)
|
24309 ELISA Units/milliliter (EU/mL)
Interval 19695.0 to 30005.0
|
NA ELISA Units/milliliter (EU/mL)
Here, NA stands for data not available for geometric mean and confidence interval (CI) as the data was below lower limit of quantification (LLOQ) of 36.11 EU/mL.
|
Adverse Events
Main Study: Ad26.ZEBOV+MVA-BN-Filo+MenACWY
Serious events: 10 serious events
Other events: 58 other events
Deaths: 0 deaths
Main Study: MenACWY (Control Arm)
Serious events: 4 serious events
Other events: 26 other events
Deaths: 0 deaths
Extension Study: Ad26.ZEBOV+MVA-BN-Filo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Main Study: Ad26.ZEBOV+MVA-BN-Filo+MenACWY
n=75 participants at risk
Healthy participants (infants) aged 4-11 months, were administered with 0.5 milliliter (mL) of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine (5\*10\^10 viral particles \[vp\]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo; 1\*10\^8 infectious units \[Inf U\]) vaccine by IM injection on Day 57. Participants also received a dose of World Health Organisation (WHO)-prequalified 0.5 mL of Meningococcal Group A, C, W135, and Y conjugate (MenACWY) vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
Main Study: MenACWY (Control Arm)
n=33 participants at risk
Healthy participants were administered with 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants also received a dose of MenACWY vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
Extension Study: Ad26.ZEBOV+MVA-BN-Filo
n=26 participants at risk
Participants who were originally randomized to the control arm and who had not withdrawn during the main study entered the extension phase to receive 0.5 mL of Ad26.ZEBOV vaccine (5\*10\^10 vp) on Day 1 by IM injection followed by 0.5 mL of MVA-BN-Filo (1\*10\^8 Inf U) vaccine by IM injection on Day 57. Participants were also followed-up for safety until 28 days post-dose 2, that is, Day 85.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
1/75 • Number of events 1 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/33 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/75 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
3.0%
1/33 • Number of events 1 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/75 • Number of events 1 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/33 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Infections and infestations
Bronchiolitis
|
1.3%
1/75 • Number of events 2 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
3.0%
1/33 • Number of events 1 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Infections and infestations
Conjunctivitis
|
1.3%
1/75 • Number of events 1 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/33 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Infections and infestations
Gastroenteritis
|
6.7%
5/75 • Number of events 5 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
3.0%
1/33 • Number of events 1 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Infections and infestations
Gastrointestinal Candidiasis
|
0.00%
0/75 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
3.0%
1/33 • Number of events 1 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Infections and infestations
Malaria
|
2.7%
2/75 • Number of events 2 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
3.0%
1/33 • Number of events 1 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Infections and infestations
Measles
|
1.3%
1/75 • Number of events 1 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/33 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
1/75 • Number of events 2 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/33 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Infections and infestations
Sepsis
|
0.00%
0/75 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
3.0%
1/33 • Number of events 1 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
2/75 • Number of events 2 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/33 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.3%
1/75 • Number of events 1 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/33 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Vascular disorders
Hypovolaemic Shock
|
0.00%
0/75 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
3.0%
1/33 • Number of events 1 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
Other adverse events
| Measure |
Main Study: Ad26.ZEBOV+MVA-BN-Filo+MenACWY
n=75 participants at risk
Healthy participants (infants) aged 4-11 months, were administered with 0.5 milliliter (mL) of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine (5\*10\^10 viral particles \[vp\]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo; 1\*10\^8 infectious units \[Inf U\]) vaccine by IM injection on Day 57. Participants also received a dose of World Health Organisation (WHO)-prequalified 0.5 mL of Meningococcal Group A, C, W135, and Y conjugate (MenACWY) vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
Main Study: MenACWY (Control Arm)
n=33 participants at risk
Healthy participants were administered with 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants also received a dose of MenACWY vaccine by IM injection at the 6-months post-dose 2 visit, that is, Day 237.
|
Extension Study: Ad26.ZEBOV+MVA-BN-Filo
n=26 participants at risk
Participants who were originally randomized to the control arm and who had not withdrawn during the main study entered the extension phase to receive 0.5 mL of Ad26.ZEBOV vaccine (5\*10\^10 vp) on Day 1 by IM injection followed by 0.5 mL of MVA-BN-Filo (1\*10\^8 Inf U) vaccine by IM injection on Day 57. Participants were also followed-up for safety until 28 days post-dose 2, that is, Day 85.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
1/75 • Number of events 1 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/33 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
7.7%
2/26 • Number of events 2 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Gastrointestinal disorders
Enteritis
|
5.3%
4/75 • Number of events 4 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/33 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Infections and infestations
Acarodermatitis
|
8.0%
6/75 • Number of events 8 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
12.1%
4/33 • Number of events 4 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Infections and infestations
Bronchitis
|
12.0%
9/75 • Number of events 10 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
21.2%
7/33 • Number of events 8 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
3.8%
1/26 • Number of events 1 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Infections and infestations
Conjunctivitis Bacterial
|
2.7%
2/75 • Number of events 3 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
6.1%
2/33 • Number of events 2 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Infections and infestations
Furuncle
|
8.0%
6/75 • Number of events 6 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
9.1%
3/33 • Number of events 3 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
3.8%
1/26 • Number of events 1 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Infections and infestations
Gastroenteritis
|
8.0%
6/75 • Number of events 6 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
6.1%
2/33 • Number of events 2 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Infections and infestations
Gastrointestinal Candidiasis
|
6.7%
5/75 • Number of events 5 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
3.0%
1/33 • Number of events 1 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Infections and infestations
Helminthic Infection
|
1.3%
1/75 • Number of events 1 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/33 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
11.5%
3/26 • Number of events 3 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Infections and infestations
Malaria
|
17.3%
13/75 • Number of events 15 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
27.3%
9/33 • Number of events 10 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
23.1%
6/26 • Number of events 9 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Infections and infestations
Nasopharyngitis
|
16.0%
12/75 • Number of events 13 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
18.2%
6/33 • Number of events 10 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Infections and infestations
Oral Candidiasis
|
9.3%
7/75 • Number of events 7 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
9.1%
3/33 • Number of events 4 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Infections and infestations
Respiratory Tract Infection
|
20.0%
15/75 • Number of events 19 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
27.3%
9/33 • Number of events 12 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
3.8%
1/26 • Number of events 2 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Infections and infestations
Rhinitis
|
13.3%
10/75 • Number of events 12 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
15.2%
5/33 • Number of events 5 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.7%
8/75 • Number of events 8 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
18.2%
6/33 • Number of events 9 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
11.5%
3/26 • Number of events 4 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
1.3%
1/75 • Number of events 1 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/33 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
7.7%
2/26 • Number of events 3 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/75 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
6.1%
2/33 • Number of events 2 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Diaper
|
5.3%
4/75 • Number of events 5 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
3.0%
1/33 • Number of events 2 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention administration documented.
|
0.00%
0/26 • Main study: Up to Day 365 ; Extension study: Up to extension Day 85
The full analysis set included all participants with at least one study intervention 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 to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER