A Phase 3 interventional study of Ad26.ZEBOV and MVA-BN-Filo in Ebola Virus Disease, sponsored by Janssen Vaccines & Prevention B.V.. Completed at 1 site in Sierra Leone. Open to participants aged 1 Year and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-18.
Sponsored by Janssen Vaccines & Prevention B.V. (part of Johnson & Johnson) · Phase 3, Interventional, and Prevention
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.
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.
104 studies on the registry are indexed under Hemorrhagic Fever, Ebola; 13 are open to participants now.
This study's enrollment of 1,023 is above the median of 94 across 81 interventional studies indexed under Hemorrhagic Fever, Ebola.
Browse Hemorrhagic Fever, Ebola studies →Janssen Vaccines & Prevention B.V. is the lead sponsor of 49 studies on the registry; none are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 32 (86%) have results posted.
First submitted after Janssen Vaccines & Prevention B.V. became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Additional Inclusion criteria Stage 2:
Exclusion Criteria:
Additional exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ad26.ZEBOV will be administered as a 0.5 milliliter (mL) intramuscular (IM) injection (Dose 1); MVA-BN-Filo will be administered as a 0.5 mL IM injection (Dose 2). The booster vaccination using Ad26.ZEBOV will be administered as a 0.5 mL IM injection (2 years post Dose 1).
Biological: Ad26.ZEBOV · Biological: MVA-BN-Filo
Ad26.ZEBOV will be administered as a 0.5 mL IM injection (Dose 1); MVA-BN-Filo will be administered as a 0.5 mL IM injection (Dose 2).
Biological: Ad26.ZEBOV · Biological: MVA-BN-Filo
Ad26.ZEBOV will be administered as a 0.5 mL IM injection (Dose 1); MVA-BN-Filo will be administered as a 0.5 mL IM injection (Dose 2). Children aged less than 2 years at randomization will receive a booster dose of vaccination at 3 months post Dose 2 with Placebo.
Biological: Ad26.ZEBOV · Biological: MVA-BN-Filo
MenACWY will be administered as a 0.5 mL IM injection on Day 1 (Dose 1) and placebo on Day 57 (Dose 2).
Biological: MenACWY · Biological: Placebo
MenACWY will be administered as a 0.5 mL IM injection on Day 1 (Dose 1) and placebo on Day 57 (Dose 2). Children aged less than 2 years at randomization will receive a booster dose of MenACWY vaccination at 3 months post Dose 2 with MenACWY.
Biological: MenACWY · Biological: Placebo
Ebola Zaire vaccine, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5\*10\^10 viral particles.
MVA-BN-Filo- is a non-replicating vaccine, 0.5 mL IM injection of 1\*10\^8 Infectious Unit (Inf. U.).
MenACWY is a WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine.
0.9% saline for injection.
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)
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)
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)
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)
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)
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)
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
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
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)
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)
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)
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)
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)
Stage 1: Number of Participants With Deaths
Number of participants with deaths were reported.
Time frame: Up to 36 months
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
Stage 2: Number of Participants With Deaths (Adults)
Number of participants (adults) with deaths were reported.
Time frame: Up to 24 months
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
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
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
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)
| Milestone | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Started | 43 | 298 | 102 | 143 | 48 | 144 | 48 | 144 | 48 |
| Completed | 28 | 217 | 64 | 132 | 43 | 133 | 45 | 137 | 46 |
| Not completed | 15 | 81 | 38 | 11 | 5 | 11 | 3 | 7 | 2 |
| Withdrew: Lost to follow-up | 8 | 47 | 19 | 6 | 3 | 3 | 1 | 3 | 1 |
| Withdrew: Physician decision | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 4 | 17 | 7 | 5 | 0 | 6 | 1 | 2 | 1 |
| Withdrew: Death | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
| Withdrew: Other | 0 | 4 | 5 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Non-compliance with study drug | 1 | 11 | 7 | 0 | 1 | 2 | 1 | 1 | 0 |
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.
| Participants | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (Day 8) | 12 | 51 | 17 | 14 | 3 | 30 | 2 | 21 | 5 |
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.
| Participants | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Stages 1 and 2: Number of Participants With Solicited Local AEs (Day 64) | 6 | 58 | 8 | 21 | 1 | 22 | 5 | 7 | 0 |
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.
| Participants | Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) |
|---|---|
| Stage 1: Number of Participants With Solicited Local AEs (Day 738) | 5 |
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).
| Participants | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 8) | 18 | 161 | 51 | 52 | 14 | 45 | 15 | 36 | 12 |
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).
| Participants | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 64) | 17 | 107 | 39 | 26 | 6 | 27 | 8 | 23 | 14 |
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).
| Participants | Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) |
|---|---|
| Stage 1: Number of Participants With Solicited Systemic AEs (Day 738) | 9 |
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.
| Participants | Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) |
|---|---|
| Stages 1: Number of Participants With Serious Adverse Events (SAEs) | 3 |
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.
| Participants | 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 |
|---|---|---|---|---|---|---|---|---|
| Stages 2: Number of Participants With SAEs | 16 | 4 | 0 | 1 | 5 | 0 | 15 | 3 |
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.
| Participants | Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) |
|---|---|
| Stage 1: Number of Participants With Unsolicited AEs (Day 759) | 5 |
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.
| Participants | Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) |
|---|---|
| Stage 1: Number of Participants With Unsolicited AEs (Day 29) | 17 |
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.
| Participants | 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 |
|---|---|---|---|---|---|---|---|---|
| Stage 2: Number of Participants With Unsolicited AEs (Day 29) | 198 | 65 | 54 | 20 | 60 | 18 | 88 | 28 |
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.
| Participants | Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) |
|---|---|
| Stage 1: Number of Participants With Unsolicited AEs (Day 85) | 17 |
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.
| Participants | 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 |
|---|---|---|---|---|---|---|---|---|
| Stage 2: Number of Participants With Unsolicited AEs (Day 85) | 145 | 48 | 49 | 13 | 46 | 13 | 92 | 31 |
Number of participants with deaths were reported.
| Participants | Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) |
|---|---|
| Stage 1: Number of Participants With Deaths | 0 |
Number of participants (children and adolescents) with deaths were reported.
| Participants | 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 |
|---|---|---|---|---|---|---|
| Stage 2: Number of Participants With Deaths (Children and Adolescents) | 0 | 1 | 0 | 0 | 1 | 0 |
Number of participants (adults) with deaths were reported.
| Participants | Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo | Stage 2 (>=18 Years): MenACWY, Placebo |
|---|---|---|
| Stage 2: Number of Participants With Deaths (Adults) | 1 | 0 |
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.
| Participants | Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) |
|---|---|
| Stage 1: Number of Participants With Immediate Reportable Event (IREs) | 0 |
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.
| Participants | 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 |
|---|---|---|---|---|---|---|
| Stage 2: Number of Participants With IREs (Children and Adolescents) | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo | Stage 2 (>=18 Years): MenACWY, Placebo |
|---|---|---|
| Stage 2: Number of Participants With IREs (Adults) | 0 | 0 |
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).
| ELISA units/mL | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 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 (3736 to 6125) | 3810 (3312 to 4383) | 50 (NA to 70) | 9929 (8172 to 12064) | 74 (48 to 114) | 10212 (8419 to 12388) | 42 (NA to 60) | 22568 (18426 to 27642) | NA (NA to 38) |
Collected over Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV) | 0/43 (0%) | 3/43 (7%) | 22/43 (51.2%) |
| Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo | 1/298 (0.3%) | 16/298 (5.4%) | 194/298 (65.1%) |
| Stage 2 (>=18 Years): MenACWY, Placebo | 0/102 (0%) | 4/102 (3.9%) | 63/102 (61.8%) |
| Stage 2 (12-17 Years): Ad26.ZEBOV, MVA-BN-Filo | 0/143 (0%) | 0/143 (0%) | 56/143 (39.2%) |
| Stage 2 (12-17 Years): MenACWY, Placebo | 1/48 (2.1%) | 1/48 (2.1%) | 18/48 (37.5%) |
| Stage 2 (4-11 Years): Ad26.ZEBOV, MVA-BN-Filo | 0/144 (0%) | 5/144 (3.5%) | 69/144 (47.9%) |
| Stage 2 (4-11 Years): MenACWY, Placebo | 0/48 (0%) | 0/48 (0%) | 21/48 (43.8%) |
| Stage 2 (1-3 Years): Ad26.ZEBOV, MVA-BN-Filo | 1/144 (0.7%) | 15/144 (10.4%) | 108/144 (75%) |
| Stage 2 (1-3 Years): MenACWY, Placebo | 0/48 (0%) | 3/48 (6.3%) | 38/48 (79.2%) |
| Event | 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 |
|---|---|---|---|---|---|---|---|---|---|
| MalariaInfections and infestations | 0/43 | 3/298 | 0/102 | 0/143 | 0/48 | 2/144 | 0/48 | 14/144 | 2/48 |
| SepsisInfections and infestations | 0/43 | 1/298 | 0/102 | 0/143 | 0/48 | 0/144 | 0/48 | 6/144 | 0/48 |
| GastroenteritisInfections and infestations | 0/43 | 2/298 | 3/102 | 0/143 | 0/48 | 1/144 | 0/48 | 0/144 | 0/48 |
| AnaemiaBlood and lymphatic system disorders | 0/43 | 1/298 | 0/102 | 0/143 | 0/48 | 1/144 | 0/48 | 4/144 | 0/48 |
| PneumoniaInfections and infestations | 0/43 | 0/298 | 0/102 | 0/143 | 0/48 | 0/144 | 0/48 | 4/144 | 0/48 |
| Retinal DetachmentEye disorders | 1/43 | 0/298 | 0/102 | 0/143 | 0/48 | 0/144 | 0/48 | 0/144 | 0/48 |
| Peptic UlcerGastrointestinal disorders | 1/43 | 0/298 | 0/102 | 0/143 | 0/48 | 0/144 | 0/48 | 0/144 | 0/48 |
| ChorioretinitisInfections and infestations | 1/43 | 0/298 | 0/102 | 0/143 | 0/48 | 0/144 | 0/48 | 0/144 | 0/48 |
| OrchitisInfections and infestations | 1/43 | 0/298 | 0/102 | 0/143 | 0/48 | 0/144 | 0/48 | 0/144 | 0/48 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/43 | 0/298 | 0/102 | 0/143 | 0/48 | 0/144 | 0/48 | 0/144 | 1/48 |
| Event | 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 |
|---|---|---|---|---|---|---|---|---|---|
| MalariaInfections and infestations | 6/43 | 123/298 | 40/102 | 35/143 | 9/48 | 50/144 | 14/48 | 81/144 | 26/48 |
| HeadacheNervous system disorders | 9/43 | 40/298 | 13/102 | 14/143 | 2/48 | 4/144 | 0/48 | 0/144 | 0/48 |
| Upper Respiratory Tract InfectionInfections and infestations | 1/43 | 16/298 | 8/102 | 3/143 | 1/48 | 9/144 | 4/48 | 26/144 | 9/48 |
| FuruncleInfections and infestations | 6/43 | 11/298 | 3/102 | 2/143 | 1/48 | 1/144 | 2/48 | 6/144 | 3/48 |
| Respiratory Tract InfectionInfections and infestations | 2/43 | 15/298 | 4/102 | 6/143 | 2/48 | 4/144 | 4/48 | 17/144 | 5/48 |
| GastroenteritisInfections and infestations | 1/43 | 10/298 | 2/102 | 1/143 | 0/48 | 3/144 | 2/48 | 7/144 | 5/48 |
| NasopharyngitisInfections and infestations | 0/43 | 21/298 | 5/102 | 1/143 | 0/48 | 5/144 | 0/48 | 6/144 | 5/48 |
| Haemoglobin DecreasedInvestigations | 0/43 | 7/298 | 2/102 | 8/143 | 5/48 | 3/144 | 1/48 | 0/144 | 0/48 |
| PainGeneral disorders | 3/43 | 16/298 | 10/102 | 3/143 | 1/48 | 0/144 | 1/48 | 0/144 | 0/48 |
| AnaemiaBlood and lymphatic system disorders | 1/43 | 2/298 | 0/102 | 1/143 | 3/48 | 6/144 | 4/48 | 13/144 | 1/48 |
| Age, Continuous(years) | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 26.9 ± 9.87 | 27.5 ± 10.46 | 29.6 ± 11.6 | 14.2 ± 1.58 | 14 ± 1.58 | 7.7 ± 1.88 | 7.9 ± 1.96 | 1.9 ± 0.79 | 1.9 ± 0.76 | 16.6 ± 12.79 |
| Sex: Female, Male(Participants) | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Female | 1 | 50 | 22 | 69 | 21 | 73 | 26 | 67 | 21 | 350 |
| Male | 42 | 248 | 80 | 74 | 27 | 71 | 22 | 77 | 27 | 668 |
| Ethnicity (NIH/OMB)(Participants) | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Not Hispanic or Latino | 43 | 298 | 102 | 143 | 47 | 144 | 48 | 144 | 48 | 1017 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 43 | 297 | 102 | 142 | 47 | 144 | 47 | 144 | 48 | 1014 |
| White | 0 | 1 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 4 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| SIERRA LEONE | 43 | 298 | 102 | 143 | 48 | 144 | 48 | 144 | 48 | 1018 |
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