Ebola Virus Disease
Conditions
Keywords
Vaccine, Ebola, Ebola virus disease, EVD, Hemorrhagic fever, Sierra Leone, Human adenovirus serotype 26 (Ad26) encoding the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV), Safety, Immunogenicity, Modified Vaccinia Virus Ankara - Bavarian Nordic Filo-vector, (MVA-BN Filo)
Brief summary
The purpose of this study is the evaluation of the safety and immunogenicity of two candidate Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo, in a 2-dose heterologous regimen.
Detailed description
This is staged Phase 3 study to gather information on the safety and immunogenicity of a 2-dose heterologous regimen. In this regimen, Ad26.ZEBOV will be administered as a Dose 1 vaccination followed by the candidate vaccine MVA-BN-Filo (Dose 2 56 days later) and a booster dose of A26.ZEBOV will be administered 2 years post Dose 1 vaccination to participants in Stage 1 who consent to this. The study will take place in Sierra Leone and will consist of a screening phase, an active phase (vaccination) and a follow-up phase. The active phase of the study will be conducted initially in two stages. In the first stage approximately 40 adults aged 18 years or older will be vaccinated to gain information about the safety and immunogenicity of the 2-dose heterologous vaccine regimen. In stage 2 a larger group of approximately 976 individuals will be vaccinated to further evaluate the safety and immunogenicity of the 2 dose heterologous vaccine regimen across different age groups. In this stage, children aged 1 year or older, adolescents and adults will be included. Solicited local and systemic adverse events will be collected until 7 days after the Dose 1 and Dose 2 vaccination. Unsolicited adverse events will be collected from signing of the informed consent form (ICF) onwards until 56 days after the Dose 2 vaccination in Stage 1 and then again from the day of the booster vaccination until 28 days after the booster vaccination, and until 28 days after each vaccination in stage 2. Serious adverse events will be collected from signing of the ICF onwards until 12 and 36 months after the Dose 1 vaccination in Stage 2 and Stage 1, respectively. These data will be reviewed by an independent data monitoring committee (IDMC) to assess whether initiation of vaccination in the next stage or age group can be provided. Safety evaluations will include assessment of adverse events, which will be monitored throughout the study. Participants in Stage 2 will be followed up for safety and immunogenicity until 12 months (children and adolescents) or 24 months (adults) after the Dose 1 vaccination. Participants in Stage 1 will be followed up for safety and immunogenicity until 36 months after the Dose 1 vaccination or until 1 year after the booster vaccination.
Interventions
BIOLOGICALAd26.ZEBOV
Ebola Zaire vaccine, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5\*10\^10 viral particles.
BIOLOGICALMVA-BN-Filo
MVA-BN-Filo- is a non-replicating vaccine, 0.5 mL IM injection of 1\*10\^8 Infectious Unit (Inf. U.).
BIOLOGICALMenACWY
MenACWY is a WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine.
BIOLOGICALPlacebo
0.9% saline for injection.
Sponsors
London School of Hygiene and Tropical Medicine
Ministry of Health and Sanitation, Sierra Leone
University of Sierra Leone
University of Oxford
Institut National de la Santé Et de la Recherche Médicale, France
Grameen Foundation
World Vision, Ireland
Janssen Vaccines & Prevention B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Stage 1 and 2: * Documented community engagement from community leader and a signed inform consent form (ICF) from each participant must be available * Participant Stage 1 must be 18 years or older at screening and be resident in selected study community with no intention to move from study area within the next 5 months * Participant must be healthy with no abnormalities in laboratory screening tests within 28 days before Dose 1 vaccination * Female participants of childbearing potential must use adequate birth control measures and must have a negative pregnancy test at screening and immediately prior to each study vaccination * Participant must pass the test of understanding (TOU) Additional Inclusion criteria Stage 2: * One year or older at screening (children of enrolled parents are eligible) * Parent/legal guardian (for children) must pass the TOU before signing the ICF * Subjects aged 7 years and older will be asked to give positive assent in the presence of a witness
Exclusion criteria
* Diagnosed with EVD or under quarantine/exposed to Ebola or body temperature equal of \>= 38 degree Celsius (fever) * Having an acute illness (mild in nature that can be treated at home) or any clinically significant acute/chronic medical condition or having a decreased number of red blood cells/hemoglobin in the blood (anemia) * Previously participated in another Ebola interventional study or received any Ad26/MVA-based candidate vaccine * Vaccinated with live attenuated vaccines within 30 days or with inactivated vaccines 15 days before Dose 1 vaccination * Treated with an immunosuppressive drug at the time of screening Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stage 2: Number of Participants With IREs (Adults) | Up to 24 months | Number of participants (adults) with IREs were reported. The following list of neuroinflammatory disorders are categorized as IREs: Cranial nerve disorders, including paralyses/paresis, optic neuritis, multiple sclerosis, transverse myelitis, guillain-Barré syndrome, acute disseminated encephalomyelitis, including site specific variants, myasthenia gravis and Lambert-Eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, narcolepsy, isolated paresthesia of greater than (\>) 7 days duration. |
| Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (Day 8) | 7 days post dose 1 (Day 8) | Number of participants with solicited local AEs were reported. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site. |
| Stages 1 and 2: Number of Participants With Solicited Local AEs (Day 64) | 7 days post dose 2 (Day 64) | Number of participants with solicited local AEs were reported. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site. |
| Stage 1: Number of Participants With Solicited Local AEs (Day 738) | 7 days post dose 3 (Day 738) | Number of participants with solicited local AEs were reported. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site. |
| Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 8) | 7 days post dose 1 (Day 8) | Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included body temperature, vomiting, reduced activity, somnolence, fatigue, irritability/fussiness/crying/screaming, and loss of appetite (for preverbal children/infants) and body temperature, nausea/vomiting, fatigue/malaise, muscle pain, chills, joint pain and headache (for young children, adolescents, and adults). |
| Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 64) | 7 days post dose 2 (Day 64) | Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included body temperature, vomiting, reduced activity, somnolence, fatigue, irritability/fussiness/crying/screaming, and loss of appetite (for preverbal children/infants) and body temperature, nausea/vomiting, fatigue/malaise, muscle pain, chills, joint pain and headache (for young children, adolescents, and adults). |
| Stage 1: Number of Participants With Solicited Systemic AEs (Day 738) | 7 days post dose 3 (Up to Day 738) | Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included body temperature, vomiting, reduced activity, somnolence, fatigue, irritability/fussiness/crying/screaming, and loss of appetite (for preverbal children/infants) and body temperature, nausea/vomiting, fatigue/malaise, muscle pain, chills, joint pain and headache (for young children, adolescents, and adults). |
| Stages 1: Number of Participants With Serious Adverse Events (SAEs) | Up to 36 months | Number of Participants with SAEs were reported. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. |
| Stages 2: Number of Participants With SAEs | Up to 24 months | Number of Participants with SAEs were reported. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. |
| Stage 1: Number of Participants With Unsolicited AEs (Day 759) | 28 days post booster dose (Day 759) | Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Stage 1: Number of Participants With Unsolicited AEs (Day 29) | 28 days post dose 1 (Day 29) | Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Stage 2: Number of Participants With Unsolicited AEs (Day 29) | 28 days post dose 1 (Day 29) | Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Stage 1: Number of Participants With Unsolicited AEs (Day 85) | 28 days post dose 2 (Day 85) | Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Stage 2: Number of Participants With Unsolicited AEs (Day 85) | 28 days post dose 2 (Day 85) | Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Stage 1: Number of Participants With Deaths | Up to 36 months | Number of participants with deaths were reported. |
| Stage 2: Number of Participants With Deaths (Children and Adolescents) | Up to 12 months | Number of participants (children and adolescents) with deaths were reported. |
| Stage 2: Number of Participants With Deaths (Adults) | Up to 24 months | Number of participants (adults) with deaths were reported. |
| Stage 1: Number of Participants With Immediate Reportable Event (IREs) | Up to 36 months | Number of participants with IREs were reported. The following list of neuroinflammatory disorders are categorized as IREs: Cranial nerve disorders, including paralyses/paresis, optic neuritis, multiple sclerosis, transverse myelitis, guillain-Barré syndrome, acute disseminated encephalomyelitis, including site specific variants, myasthenia gravis and Lambert-Eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, narcolepsy, isolated paresthesia of greater than (\>) 7 days duration. |
| Stage 2: Number of Participants With IREs (Children and Adolescents) | Up to 12 months | Number of participants (children and adolescents) with IREs were reported. The following list of neuroinflammatory disorders are categorized as IREs: Cranial nerve disorders, including paralyses/paresis, optic neuritis, multiple sclerosis, transverse myelitis, guillain-Barré syndrome, acute disseminated encephalomyelitis, including site specific variants, myasthenia gravis and Lambert-Eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, narcolepsy, isolated paresthesia of greater than (\>) 7 days duration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stages 1 and 2: Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Enzyme-linked Immunosorbent Assay (ELISA) | 21 days post-dose 2 (Day 78) | GMCs of antibodies binding to EBOV GP using ELISA were reported and were measured in ELISA units per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the lower limit of quantification (LLOQ) (36.11 ELISA units/mL). |
Countries
Sierra Leone
Participant flow
Pre-assignment details
Out of 1023 participants who signed informed consent form, only 1018 participants were randomized and received study treatment and were included in the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 viral particles (vp) intramuscular (IM) injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 infectious units (Inf.U) as Dose 2 on Day 57. Participants received a third vaccination with Ad26.ZEBOV 5\*10\^10 vp as a booster dose 2 years post dose 1 (Day 731). | 43 |
| Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo Participants with \>=18 years of age (adults) received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as Dose 2 on Day 57. | 298 |
| Stage 2 (>=18 Years): MenACWY, Placebo Participants with \>=18 years of age (adults) received MenACWY 0.5 milliliter (mL) IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57. | 102 |
| Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo Participants with 12-17 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 Inf.U as dose 2 on Day 57. | 143 |
| Stage 2 (12-17 Years): MenACWY, Placebo Participants with 12-17 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57. | 48 |
| Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo Participants with 4-11 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1 followed by IM injection of MVA-BN-Filo 1\*10\^8 Inf.U as Dose 2 on Day 57. | 144 |
| Stage 2 (4-11 Years): MenACWY, Placebo Participants with 4-11 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57. | 48 |
| Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo Participants with 1-3 years of age received Ad26.ZEBOV 5\*10\^10 vp IM injection as Dose 1 on Day 1, followed by IM injection of MVA-BN-filo 1\*10\^8 inf.U as Dose 2 on Day 57, and placebo on Day 156. Third dose (placebo) is only for children less than two years old who reconsented. | 144 |
| Stage 2 (1-3 Years): MenACWY, Placebo Participants with 1-3 years of age received MenACWY 0.5 mL IM injection as Dose 1 on Day 1, followed by IM injection of placebo on Day 57 and then IM injection of MenACWY 0.5 mL on Day 156. Third dose (MenACWY) is only for children less than two years old who reconsented. | 48 |
| Total | 1,018 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 8 | 47 | 19 | 6 | 3 | 3 | 1 | 3 | 1 |
| Overall Study | Non-Compliance With Study Drug | 1 | 11 | 7 | 0 | 1 | 2 | 1 | 1 | 0 |
| Overall Study | Other | 0 | 4 | 5 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 17 | 7 | 5 | 0 | 6 | 1 | 2 | 1 |
Baseline characteristics
| Characteristic | Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo | Stage 2 (>=18 Years): MenACWY, Placebo | Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo | Stage 2 (12-17 Years): MenACWY, Placebo | Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo | Stage 2 (4-11 Years): MenACWY, Placebo | Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo | Stage 2 (1-3 Years): MenACWY, Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 26.9 years STANDARD_DEVIATION 9.87 | 27.5 years STANDARD_DEVIATION 10.46 | 29.6 years STANDARD_DEVIATION 11.6 | 14.2 years STANDARD_DEVIATION 1.58 | 14 years STANDARD_DEVIATION 1.58 | 7.7 years STANDARD_DEVIATION 1.88 | 7.9 years STANDARD_DEVIATION 1.96 | 1.9 years STANDARD_DEVIATION 0.79 | 1.9 years STANDARD_DEVIATION 0.76 | 16.6 years STANDARD_DEVIATION 12.79 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 298 Participants | 102 Participants | 143 Participants | 47 Participants | 144 Participants | 48 Participants | 144 Participants | 48 Participants | 1017 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 43 Participants | 297 Participants | 102 Participants | 142 Participants | 47 Participants | 144 Participants | 47 Participants | 144 Participants | 48 Participants | 1014 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants |
| Region of Enrollment SIERRA LEONE | 43 Participants | 298 Participants | 102 Participants | 143 Participants | 48 Participants | 144 Participants | 48 Participants | 144 Participants | 48 Participants | 1018 Participants |
| Sex: Female, Male Female | 1 Participants | 50 Participants | 22 Participants | 69 Participants | 21 Participants | 73 Participants | 26 Participants | 67 Participants | 21 Participants | 350 Participants |
| Sex: Female, Male Male | 42 Participants | 248 Participants | 80 Participants | 74 Participants | 27 Participants | 71 Participants | 22 Participants | 77 Participants | 27 Participants | 668 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 1 / 298 | 0 / 102 | 0 / 143 | 1 / 48 | 0 / 144 | 0 / 48 | 1 / 144 | 0 / 48 |
| other Total, other adverse events | 22 / 43 | 194 / 298 | 63 / 102 | 56 / 143 | 18 / 48 | 69 / 144 | 21 / 48 | 108 / 144 | 38 / 48 |
| serious Total, serious adverse events | 3 / 43 | 16 / 298 | 4 / 102 | 0 / 143 | 1 / 48 | 5 / 144 | 0 / 48 | 15 / 144 | 3 / 48 |
Outcome results
Primary
Stage 1: Number of Participants With Deaths
Number of participants with deaths were reported.
Time frame: Up to 36 months
Population: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | Stage 1: Number of Participants With Deaths | 0 Participants |
Primary
Stage 1: Number of Participants With Immediate Reportable Event (IREs)
Number of participants with IREs were reported. The following list of neuroinflammatory disorders are categorized as IREs: Cranial nerve disorders, including paralyses/paresis, optic neuritis, multiple sclerosis, transverse myelitis, guillain-Barré syndrome, acute disseminated encephalomyelitis, including site specific variants, myasthenia gravis and Lambert-Eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, narcolepsy, isolated paresthesia of greater than (\>) 7 days duration.
Time frame: Up to 36 months
Population: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | Stage 1: Number of Participants With Immediate Reportable Event (IREs) | 0 Participants |
Primary
Stage 1: Number of Participants With Solicited Local AEs (Day 738)
Number of participants with solicited local AEs were reported. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Time frame: 7 days post dose 3 (Day 738)
Population: The FAS included all participants who received booster dose with Ad26.ZEBOV, regardless of the occurrence of protocol deviations. This outcome measure was only planned for participants who received booster vaccination with Ad26.ZEBOV hence other arms are not reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | Stage 1: Number of Participants With Solicited Local AEs (Day 738) | 5 Participants |
Primary
Stage 1: Number of Participants With Solicited Systemic AEs (Day 738)
Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included body temperature, vomiting, reduced activity, somnolence, fatigue, irritability/fussiness/crying/screaming, and loss of appetite (for preverbal children/infants) and body temperature, nausea/vomiting, fatigue/malaise, muscle pain, chills, joint pain and headache (for young children, adolescents, and adults).
Time frame: 7 days post dose 3 (Up to Day 738)
Population: The FAS included all participants who received booster dose with Ad26.ZEBOV, regardless of the occurrence of protocol deviations. This outcome measure was only planned for participants who received booster vaccination with Ad26.ZEBOV hence other arms are not reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | Stage 1: Number of Participants With Solicited Systemic AEs (Day 738) | 9 Participants |
Primary
Stage 1: Number of Participants With Unsolicited AEs (Day 29)
Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days post dose 1 (Day 29)
Population: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | Stage 1: Number of Participants With Unsolicited AEs (Day 29) | 17 Participants |
Primary
Stage 1: Number of Participants With Unsolicited AEs (Day 759)
Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days post booster dose (Day 759)
Population: The FAS included all participants who received booster dose with Ad26.ZEBOV, regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | Stage 1: Number of Participants With Unsolicited AEs (Day 759) | 5 Participants |
Primary
Stage 1: Number of Participants With Unsolicited AEs (Day 85)
Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days post dose 2 (Day 85)
Population: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | Stage 1: Number of Participants With Unsolicited AEs (Day 85) | 17 Participants |
Primary
Stage 2: Number of Participants With Deaths (Adults)
Number of participants (adults) with deaths were reported.
Time frame: Up to 24 months
Population: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | Stage 2: Number of Participants With Deaths (Adults) | 1 Participants |
| Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo | Stage 2: Number of Participants With Deaths (Adults) | 0 Participants |
Primary
Stage 2: Number of Participants With Deaths (Children and Adolescents)
Number of participants (children and adolescents) with deaths were reported.
Time frame: Up to 12 months
Population: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | Stage 2: Number of Participants With Deaths (Children and Adolescents) | 0 Participants |
| Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo | Stage 2: Number of Participants With Deaths (Children and Adolescents) | 1 Participants |
| Stage 2 (>=18 Years): MenACWY, Placebo | Stage 2: Number of Participants With Deaths (Children and Adolescents) | 0 Participants |
| Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo | Stage 2: Number of Participants With Deaths (Children and Adolescents) | 0 Participants |
| Stage 2 (12-17 Years): MenACWY, Placebo | Stage 2: Number of Participants With Deaths (Children and Adolescents) | 1 Participants |
| Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo | Stage 2: Number of Participants With Deaths (Children and Adolescents) | 0 Participants |
Primary
Stage 2: Number of Participants With IREs (Adults)
Number of participants (adults) with IREs were reported. The following list of neuroinflammatory disorders are categorized as IREs: Cranial nerve disorders, including paralyses/paresis, optic neuritis, multiple sclerosis, transverse myelitis, guillain-Barré syndrome, acute disseminated encephalomyelitis, including site specific variants, myasthenia gravis and Lambert-Eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, narcolepsy, isolated paresthesia of greater than (\>) 7 days duration.
Time frame: Up to 24 months
Population: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | Stage 2: Number of Participants With IREs (Adults) | 0 Participants |
| Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo | Stage 2: Number of Participants With IREs (Adults) | 0 Participants |
Primary
Stage 2: Number of Participants With IREs (Children and Adolescents)
Number of participants (children and adolescents) with IREs were reported. The following list of neuroinflammatory disorders are categorized as IREs: Cranial nerve disorders, including paralyses/paresis, optic neuritis, multiple sclerosis, transverse myelitis, guillain-Barré syndrome, acute disseminated encephalomyelitis, including site specific variants, myasthenia gravis and Lambert-Eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, narcolepsy, isolated paresthesia of greater than (\>) 7 days duration.
Time frame: Up to 12 months
Population: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | Stage 2: Number of Participants With IREs (Children and Adolescents) | 0 Participants |
| Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo | Stage 2: Number of Participants With IREs (Children and Adolescents) | 0 Participants |
| Stage 2 (>=18 Years): MenACWY, Placebo | Stage 2: Number of Participants With IREs (Children and Adolescents) | 0 Participants |
| Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo | Stage 2: Number of Participants With IREs (Children and Adolescents) | 0 Participants |
| Stage 2 (12-17 Years): MenACWY, Placebo | Stage 2: Number of Participants With IREs (Children and Adolescents) | 0 Participants |
| Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo | Stage 2: Number of Participants With IREs (Children and Adolescents) | 0 Participants |
Primary
Stage 2: Number of Participants With Unsolicited AEs (Day 29)
Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days post dose 1 (Day 29)
Population: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | Stage 2: Number of Participants With Unsolicited AEs (Day 29) | 198 Participants |
| Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo | Stage 2: Number of Participants With Unsolicited AEs (Day 29) | 65 Participants |
| Stage 2 (>=18 Years): MenACWY, Placebo | Stage 2: Number of Participants With Unsolicited AEs (Day 29) | 54 Participants |
| Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo | Stage 2: Number of Participants With Unsolicited AEs (Day 29) | 20 Participants |
| Stage 2 (12-17 Years): MenACWY, Placebo | Stage 2: Number of Participants With Unsolicited AEs (Day 29) | 60 Participants |
| Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo | Stage 2: Number of Participants With Unsolicited AEs (Day 29) | 18 Participants |
| Stage 2 (4-11 Years): MenACWY, Placebo | Stage 2: Number of Participants With Unsolicited AEs (Day 29) | 88 Participants |
| Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo | Stage 2: Number of Participants With Unsolicited AEs (Day 29) | 28 Participants |
Primary
Stage 2: Number of Participants With Unsolicited AEs (Day 85)
Number of participants with unsolicited AEs were reported. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days post dose 2 (Day 85)
Population: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | Stage 2: Number of Participants With Unsolicited AEs (Day 85) | 145 Participants |
| Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo | Stage 2: Number of Participants With Unsolicited AEs (Day 85) | 48 Participants |
| Stage 2 (>=18 Years): MenACWY, Placebo | Stage 2: Number of Participants With Unsolicited AEs (Day 85) | 49 Participants |
| Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo | Stage 2: Number of Participants With Unsolicited AEs (Day 85) | 13 Participants |
| Stage 2 (12-17 Years): MenACWY, Placebo | Stage 2: Number of Participants With Unsolicited AEs (Day 85) | 46 Participants |
| Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo | Stage 2: Number of Participants With Unsolicited AEs (Day 85) | 13 Participants |
| Stage 2 (4-11 Years): MenACWY, Placebo | Stage 2: Number of Participants With Unsolicited AEs (Day 85) | 92 Participants |
| Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo | Stage 2: Number of Participants With Unsolicited AEs (Day 85) | 31 Participants |
Primary
Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (Day 8)
Number of participants with solicited local AEs were reported. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Time frame: 7 days post dose 1 (Day 8)
Population: The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (Day 8) | 12 Participants |
| Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (Day 8) | 51 Participants |
| Stage 2 (>=18 Years): MenACWY, Placebo | Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (Day 8) | 17 Participants |
| Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (Day 8) | 14 Participants |
| Stage 2 (12-17 Years): MenACWY, Placebo | Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (Day 8) | 3 Participants |
| Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (Day 8) | 30 Participants |
| Stage 2 (4-11 Years): MenACWY, Placebo | Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (Day 8) | 2 Participants |
| Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (Day 8) | 21 Participants |
| Stage 2 (1-3 Years): MenACWY, Placebo | Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (Day 8) | 5 Participants |
Primary
Stages 1 and 2: Number of Participants With Solicited Local AEs (Day 64)
Number of participants with solicited local AEs were reported. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Time frame: 7 days post dose 2 (Day 64)
Population: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | Stages 1 and 2: Number of Participants With Solicited Local AEs (Day 64) | 6 Participants |
| Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 1 and 2: Number of Participants With Solicited Local AEs (Day 64) | 58 Participants |
| Stage 2 (>=18 Years): MenACWY, Placebo | Stages 1 and 2: Number of Participants With Solicited Local AEs (Day 64) | 8 Participants |
| Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 1 and 2: Number of Participants With Solicited Local AEs (Day 64) | 21 Participants |
| Stage 2 (12-17 Years): MenACWY, Placebo | Stages 1 and 2: Number of Participants With Solicited Local AEs (Day 64) | 1 Participants |
| Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 1 and 2: Number of Participants With Solicited Local AEs (Day 64) | 22 Participants |
| Stage 2 (4-11 Years): MenACWY, Placebo | Stages 1 and 2: Number of Participants With Solicited Local AEs (Day 64) | 5 Participants |
| Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 1 and 2: Number of Participants With Solicited Local AEs (Day 64) | 7 Participants |
| Stage 2 (1-3 Years): MenACWY, Placebo | Stages 1 and 2: Number of Participants With Solicited Local AEs (Day 64) | 0 Participants |
Primary
Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 64)
Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included body temperature, vomiting, reduced activity, somnolence, fatigue, irritability/fussiness/crying/screaming, and loss of appetite (for preverbal children/infants) and body temperature, nausea/vomiting, fatigue/malaise, muscle pain, chills, joint pain and headache (for young children, adolescents, and adults).
Time frame: 7 days post dose 2 (Day 64)
Population: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 64) | 17 Participants |
| Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 64) | 107 Participants |
| Stage 2 (>=18 Years): MenACWY, Placebo | Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 64) | 39 Participants |
| Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 64) | 26 Participants |
| Stage 2 (12-17 Years): MenACWY, Placebo | Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 64) | 6 Participants |
| Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 64) | 27 Participants |
| Stage 2 (4-11 Years): MenACWY, Placebo | Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 64) | 8 Participants |
| Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 64) | 23 Participants |
| Stage 2 (1-3 Years): MenACWY, Placebo | Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 64) | 14 Participants |
Primary
Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 8)
Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included body temperature, vomiting, reduced activity, somnolence, fatigue, irritability/fussiness/crying/screaming, and loss of appetite (for preverbal children/infants) and body temperature, nausea/vomiting, fatigue/malaise, muscle pain, chills, joint pain and headache (for young children, adolescents, and adults).
Time frame: 7 days post dose 1 (Day 8)
Population: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 8) | 18 Participants |
| Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 8) | 161 Participants |
| Stage 2 (>=18 Years): MenACWY, Placebo | Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 8) | 51 Participants |
| Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 8) | 52 Participants |
| Stage 2 (12-17 Years): MenACWY, Placebo | Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 8) | 14 Participants |
| Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 8) | 45 Participants |
| Stage 2 (4-11 Years): MenACWY, Placebo | Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 8) | 15 Participants |
| Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 8) | 36 Participants |
| Stage 2 (1-3 Years): MenACWY, Placebo | Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 8) | 12 Participants |
Primary
Stages 1: Number of Participants With Serious Adverse Events (SAEs)
Number of Participants with SAEs were reported. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Time frame: Up to 36 months
Population: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | Stages 1: Number of Participants With Serious Adverse Events (SAEs) | 3 Participants |
Primary
Stages 2: Number of Participants With SAEs
Number of Participants with SAEs were reported. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Time frame: Up to 24 months
Population: The FAS included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | Stages 2: Number of Participants With SAEs | 16 Participants |
| Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 2: Number of Participants With SAEs | 4 Participants |
| Stage 2 (>=18 Years): MenACWY, Placebo | Stages 2: Number of Participants With SAEs | 0 Participants |
| Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 2: Number of Participants With SAEs | 1 Participants |
| Stage 2 (12-17 Years): MenACWY, Placebo | Stages 2: Number of Participants With SAEs | 5 Participants |
| Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 2: Number of Participants With SAEs | 0 Participants |
| Stage 2 (4-11 Years): MenACWY, Placebo | Stages 2: Number of Participants With SAEs | 15 Participants |
| Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 2: Number of Participants With SAEs | 3 Participants |
Secondary
Stages 1 and 2: Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Enzyme-linked Immunosorbent Assay (ELISA)
GMCs of antibodies binding to EBOV GP using ELISA were reported and were measured in ELISA units per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the lower limit of quantification (LLOQ) (36.11 ELISA units/mL).
Time frame: 21 days post-dose 2 (Day 78)
Population: The per protocol analysis set included all randomized and vaccinated participants, who received both the prime and boost vaccinations had at least 1 post-vaccination evaluable immunogenicity sample, and had no major protocol violations influencing the immune response. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | Stages 1 and 2: Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Enzyme-linked Immunosorbent Assay (ELISA) | 4784 ELISA units/mL |
| Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 1 and 2: Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Enzyme-linked Immunosorbent Assay (ELISA) | 3810 ELISA units/mL |
| Stage 2 (>=18 Years): MenACWY, Placebo | Stages 1 and 2: Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Enzyme-linked Immunosorbent Assay (ELISA) | 50 ELISA units/mL |
| Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 1 and 2: Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Enzyme-linked Immunosorbent Assay (ELISA) | 9929 ELISA units/mL |
| Stage 2 (12-17 Years): MenACWY, Placebo | Stages 1 and 2: Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Enzyme-linked Immunosorbent Assay (ELISA) | 74 ELISA units/mL |
| Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 1 and 2: Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Enzyme-linked Immunosorbent Assay (ELISA) | 10212 ELISA units/mL |
| Stage 2 (4-11 Years): MenACWY, Placebo | Stages 1 and 2: Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Enzyme-linked Immunosorbent Assay (ELISA) | 42 ELISA units/mL |
| Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo | Stages 1 and 2: Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Enzyme-linked Immunosorbent Assay (ELISA) | 22568 ELISA units/mL |
| Stage 2 (1-3 Years): MenACWY, Placebo | Stages 1 and 2: Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Enzyme-linked Immunosorbent Assay (ELISA) | NA ELISA units/mL |