Staged Phase 3 Study to Assess the Safety and Immunogenic... | NCT02509494 | Trialant
NCT02509494
Sponsor
Janssen Vaccines & Prevention B.V.
Status
Completed
Last Update Posted
Jul 18, 2022Actual
Enrollment
1,023Actual
Phase
Phase 3
Conditions
Ebola Virus Disease
Interventions
Ad26.ZEBOV
MVA-BN-Filo
MenACWY
Placebo
Countries
Sierra Leone
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT02509494
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR107372
Secondary IDs
ID
Type
Description
Link
VAC52150EBL3001
Other Identifier
Janssen Vaccines & Prevention B.V.
115854 EBOVAC1
Other Grant/Funding Number
The Trial is financed within the IMI-2 Ebola program
2019-000691-42
EudraCT Number
Brief Title
Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo
Official Title
A Staged Phase 3 Study, Including a Double-Blinded Controlled Stage to Evaluate the Safety and Immunogenicity of Ad26.ZEBOV and MVA-BN-Filo as Candidate Prophylactic Vaccines for Ebola
Acronym
EBOVAC-Salone
Organization
Janssen Vaccines & Prevention B.V.INDUSTRY
Status Module
Record Verification Date
Jun 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 30, 2015Actual
Primary Completion Date
Jun 28, 2019Actual
Completion Date
Jul 3, 2019Actual
First Submitted Date
Jun 24, 2015
First Submission Date that Met QC Criteria
Jul 27, 2015
First Posted Date
Jul 28, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 22, 2022
Results First Submitted that Met QC Criteria
Jun 22, 2022
Results First Posted Date
Jul 18, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 25, 2020
Certification/Extension First Submitted that Passed QC Review
Jun 25, 2020
Certification/Extension First Posted Date
Jun 29, 2020Actual
Last Update Submitted Date
Jun 22, 2022
Last Update Posted Date
Jul 18, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Vaccines & Prevention B.V.INDUSTRY
Collaborators
Name
Class
London School of Hygiene and Tropical Medicine
OTHER
Ministry of Health and Sanitation, Sierra Leone
OTHER_GOV
University of Sierra Leone
OTHER
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Ebola Virus Disease
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)
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,023Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Stage 1: Active vaccination
Experimental
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
Stage 2: Active vaccination
Experimental
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
Stage 2: Active vaccination for children
Experimental
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
Stage 2: Control vaccination
Active Comparator
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
Stage 2: Control vaccination for children
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ad26.ZEBOV
Biological
Ebola Zaire vaccine, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
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.
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.
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).
Secondary Outcomes
Measure
Description
Time Frame
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).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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 exclusion criteria:
- Children up to 5 years of age with severe malnutrition (underweight or Z-score weight <2)
Barry H, Lhomme E, Surenaud M, Nouctara M, Robinson C, Bockstal V, Valea I, Somda S, Tinto H, Meda N, Greenwood B, Thiebaut R, Lacabaratz C. Helminth exposure and immune response to the two-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen. PLoS Negl Trop Dis. 2024 Apr 11;18(4):e0011500. doi: 10.1371/journal.pntd.0011500. eCollection 2024 Apr.
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 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).
FG001
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.
FG002
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.
FG003
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.
FG004
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.
FG005
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.
FG006
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.
FG007
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.
FG008
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.
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).
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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.
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
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).
Adverse Events Module
Frequency Threshold
5
Time Frame
Stage 1: Up to 36 months, Stage 2 (Children and Adolescents): Up to 12 months, Stage 2 (Adults): Up to 24 months
Description
The Full Analysis Set (FAS) included all participants who received at least one dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or control), regardless of the occurrence of protocol deviations.
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).
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
Stage 1: Active vaccination
Stage 2: Active vaccination
Stage 2: Active vaccination for children
MVA-BN-Filo
Biological
MVA-BN-Filo- is a non-replicating vaccine, 0.5 mL IM injection of 1*10^8 Infectious Unit (Inf. U.).
Stage 1: Active vaccination
Stage 2: Active vaccination
Stage 2: Active vaccination for children
MenACWY
Biological
MenACWY is a WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine.
Stage 2: Control vaccination
Stage 2: Control vaccination for children
Placebo
Biological
0.9% saline for injection.
Stage 2: Control vaccination
Stage 2: Control vaccination for children
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).
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).
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.
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.
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.
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.
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.
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.
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.
28 days post dose 2 (Day 85)
Stage 1: Number of Participants With Deaths
Number of participants with deaths were reported.
Up to 36 months
Stage 2: Number of Participants With Deaths (Children and Adolescents)
Number of participants (children and adolescents) with deaths were reported.
Up to 12 months
Stage 2: Number of Participants With Deaths (Adults)
Number of participants (adults) with deaths were reported.
Up to 24 months
Stage 1: Number of Participants With Immediate Reportable Event (IREs)
Mooney T, Smout E, Leigh B, Greenwood B, Enria L, Ishola D, Manno D, Samai M, Douoguih M, Watson-Jones D. EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country. Clin Trials. 2018 Oct;15(5):436-443. doi: 10.1177/1740774518780678. Epub 2018 Jun 12.
43 subjects
FG005133 subjects
FG00645 subjects
FG007137 subjects
FG00846 subjects
5 subjects
FG00511 subjects
FG0063 subjects
FG0077 subjects
FG0082 subjects
6 subjects
FG0043 subjects
FG0053 subjects
FG0061 subjects
FG0073 subjects
FG0081 subjects
Physician Decision
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Withdrawal by Subject
FG0004 subjects
FG00117 subjects
FG0027 subjects
FG0035 subjects
FG0040 subjects
FG0056 subjects
FG0061 subjects
FG0072 subjects
FG0081 subjects
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
Other
FG0000 subjects
FG0014 subjects
FG0025 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Non-Compliance With Study Drug
FG0001 subjects
FG00111 subjects
FG0027 subjects
FG0030 subjects
FG0041 subjects
FG0052 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
BG001
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.
BG002
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.
BG003
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.
BG004
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.
BG005
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.
BG006
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.
BG007
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.
BG008
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.
BG009
Total
Total of all reporting groups
43
BG001298
BG002102
BG003143
BG00448
BG005144
BG00648
BG007144
BG00848
BG0091018
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00026.9± 9.87
BG00127.5± 10.46
BG00229.6± 11.6
BG00314.2± 1.58
BG00414± 1.58
BG0057.7± 1.88
BG0067.9± 1.96
BG0071.9± 0.79
BG0081.9± 0.76
BG00916.6± 12.79
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG00150
BG00222
BG00369
BG00421
BG00573
BG00626
BG00767
BG00821
BG009350
Male
BG00042
BG001248
BG00280
BG00374
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0060
BG0070
BG0080
BG0091
Not Hispanic or Latino
BG00043
BG001298
BG002102
BG003143
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG00043
BG001297
BG002102
BG003142
BG004
White
BG0000
BG0011
BG0020
BG0031
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
SIERRA LEONE
Title
Measurements
BG00043
BG001298
BG002102
BG003143
BG00448
BG005144
BG00648
BG007144
BG00848
BG0091018
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00043
OG001298
OG002102
OG003143
OG00448
OG005144
OG00648
OG007144
OG00848
Title
Denominators
Categories
Title
Measurements
OG00012
OG00151
OG00217
OG00314
OG0043
OG00530
OG0062
OG00721
OG0085
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.
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.
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).
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00043
OG001246
OG00286
OG003
Title
Denominators
Categories
Title
Measurements
OG0006
OG00158
OG0028
OG003
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.
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.
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).
Units
Counts
Participants
OG00029
Title
Denominators
Categories
Title
Measurements
OG0005
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).
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.
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).
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00043
OG001298
OG002102
OG003
Title
Denominators
Categories
Title
Measurements
OG00018
OG001161
OG00251
OG003
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).
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.
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).
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00043
OG001246
OG00286
OG003
Title
Denominators
Categories
Title
Measurements
OG00017
OG001107
OG00239
OG003
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).
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.
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).
Units
Counts
Participants
OG00029
Title
Denominators
Categories
Title
Measurements
OG0009
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.
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.
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).
Units
Counts
Participants
OG00043
Title
Denominators
Categories
Title
Measurements
OG0003
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.
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.
Posted
Count of Participants
Participants
Up to 24 months
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG000298
OG001102
OG002143
OG003
Title
Denominators
Categories
Title
Measurements
OG00016
OG0014
OG0020
OG003
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.
The FAS included all participants who received booster dose with Ad26.ZEBOV, regardless of the occurrence of protocol deviations.
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).
Units
Counts
Participants
OG00029
Title
Denominators
Categories
Title
Measurements
OG0005
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.
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.
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).
Units
Counts
Participants
OG00043
Title
Denominators
Categories
Title
Measurements
OG00017
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.
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.
Posted
Count of Participants
Participants
28 days post dose 1 (Day 29)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG000298
OG001102
OG002143
OG003
Title
Denominators
Categories
Title
Measurements
OG000198
OG00165
OG00254
OG003
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.
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.
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).
Units
Counts
Participants
OG00043
Title
Denominators
Categories
Title
Measurements
OG00017
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.
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.
Posted
Count of Participants
Participants
28 days post dose 2 (Day 85)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG000246
OG00186
OG002142
OG003
Title
Denominators
Categories
Title
Measurements
OG000145
OG00148
OG00249
OG003
Primary
Stage 1: Number of Participants With Deaths
Number of participants with deaths were reported.
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.
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).
Units
Counts
Participants
OG00043
Title
Denominators
Categories
Title
Measurements
OG0000
Primary
Stage 2: Number of Participants With Deaths (Children and Adolescents)
Number of participants (children and adolescents) with deaths were reported.
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.
Posted
Count of Participants
Participants
Up to 12 months
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG000143
OG00148
OG002144
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG003
Primary
Stage 2: Number of Participants With Deaths (Adults)
Number of participants (adults) with deaths were reported.
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.
Posted
Count of Participants
Participants
Up to 24 months
ID
Title
Description
OG000
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.
OG001
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.
Units
Counts
Participants
OG000298
OG001102
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
Primary
Stage 1: Number of Participants With Immediate Reportable Event (IREs)
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.
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).
Units
Counts
Participants
OG00043
Title
Denominators
Categories
Title
Measurements
OG0000
Primary
Stage 2: Number of Participants With IREs (Children and Adolescents)
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.
Posted
Count of Participants
Participants
Up to 12 months
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG000143
OG00148
OG002144
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Stage 2: Number of Participants With IREs (Adults)
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.
Posted
Count of Participants
Participants
Up to 24 months
ID
Title
Description
OG000
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.
OG001
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.
Units
Counts
Participants
OG000298
OG001102
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
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).
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.
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).
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG00042
OG001182
OG00262
OG003
Title
Denominators
Categories
Title
Measurements
OG0004784(3736 to 6125)
OG0013810(3312 to 4383)
OG00250(NA to 70)Here, 'NA' signifies that lower limit of calculated 95% CI was less than LLOQ.
0
43
3
43
22
43
EG001
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.
1
298
16
298
194
298
EG002
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.
0
102
4
102
63
102
EG003
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.
0
143
0
143
56
143
EG004
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.
1
48
1
48
18
48
EG005
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.
0
144
5
144
69
144
EG006
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.
0
48
0
48
21
48
EG007
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.
1
144
15
144
108
144
EG008
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.
0
48
3
48
38
48
EG0000 affected43 at risk
EG0011 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0051 affected144 at risk
EG0060 affected48 at risk
EG0074 affected144 at risk
EG0080 affected48 at risk
Anaemia of Pregnancy
Blood and lymphatic system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0011 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Iron Deficiency Anaemia
Blood and lymphatic system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0010 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0071 affected144 at risk
EG0080 affected48 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0010 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0081 affected48 at risk
Retinal Detachment
Eye disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected43 at risk
EG0010 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0011 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Peptic Ulcer
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected43 at risk
EG0010 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Appendicitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0012 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Brain Abscess
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0011 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Bronchiolitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0010 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0071 affected144 at risk
EG0080 affected48 at risk
Chorioretinitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected43 at risk
EG0010 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Gastroenteritis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0012 affected298 at risk
EG0023 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0051 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Helminthic Infection
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0011 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Malaria
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0013 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0052 affected144 at risk
EG0060 affected48 at risk
EG00714 affected144 at risk
EG0082 affected48 at risk
Meningitis Bacterial
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0010 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0071 affected144 at risk
EG0081 affected48 at risk
Orchitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected43 at risk
EG0010 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Osteomyelitis Chronic
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0010 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0051 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Peritonitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0010 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0051 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Pneumonia
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0010 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0074 affected144 at risk
EG0080 affected48 at risk
Postoperative Wound Infection
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0010 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0051 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Respiratory Tract Infection
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0010 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0051 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Sepsis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0011 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0076 affected144 at risk
EG0080 affected48 at risk
Subcutaneous Abscess
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0011 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0071 affected144 at risk
EG0080 affected48 at risk
Typhoid Fever
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0010 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0041 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Abortion Induced Incomplete
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0011 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Chest Injury
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0011 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Head Injury
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0012 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Ligament Sprain
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0011 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Multiple Injuries
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0011 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Open Globe Injury
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0011 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Radius Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0011 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Skin Laceration
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0011 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0011 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Febrile Convulsion
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0010 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0071 affected144 at risk
EG0080 affected48 at risk
Syncope
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0010 affected298 at risk
EG0021 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Abortion Threatened
Pregnancy, puerperium and perinatal conditions
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0011 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Haemorrhage in Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0011 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Placenta Praevia
Pregnancy, puerperium and perinatal conditions
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0011 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Premature Labour
Pregnancy, puerperium and perinatal conditions
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0011 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Renal Haematoma
Renal and urinary disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0010 affected298 at risk
EG0021 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0010 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0051 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Hypovolaemic Shock
Vascular disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0011 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
EG0001 affected43 at risk
EG0012 affected298 at risk
EG0020 affected102 at risk
EG0031 affected143 at risk
EG0043 affected48 at risk
EG0056 affected144 at risk
EG0064 affected48 at risk
EG00713 affected144 at risk
EG0081 affected48 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0012 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0051 affected144 at risk
EG0060 affected48 at risk
EG0078 affected144 at risk
EG0083 affected48 at risk
Peptic Ulcer
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG00115 affected298 at risk
EG0021 affected102 at risk
EG0030 affected143 at risk
EG0041 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Pain
General disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0003 affected43 at risk
EG00116 affected298 at risk
EG00210 affected102 at risk
EG0033 affected143 at risk
EG0041 affected48 at risk
EG0050 affected144 at risk
EG0061 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Furuncle
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0006 affected43 at risk
EG00111 affected298 at risk
EG0023 affected102 at risk
EG0032 affected143 at risk
EG0041 affected48 at risk
EG0051 affected144 at risk
EG0062 affected48 at risk
EG0076 affected144 at risk
EG0083 affected48 at risk
Gastroenteritis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected43 at risk
EG00110 affected298 at risk
EG0022 affected102 at risk
EG0031 affected143 at risk
EG0040 affected48 at risk
EG0053 affected144 at risk
EG0062 affected48 at risk
EG0077 affected144 at risk
EG0085 affected48 at risk
Malaria
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0006 affected43 at risk
EG001123 affected298 at risk
EG00240 affected102 at risk
EG00335 affected143 at risk
EG0049 affected48 at risk
EG00550 affected144 at risk
EG00614 affected48 at risk
EG00781 affected144 at risk
EG00826 affected48 at risk
Nasopharyngitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG00121 affected298 at risk
EG0025 affected102 at risk
EG0031 affected143 at risk
EG0040 affected48 at risk
EG0055 affected144 at risk
EG0060 affected48 at risk
EG0076 affected144 at risk
EG0085 affected48 at risk
Respiratory Tract Infection
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0002 affected43 at risk
EG00115 affected298 at risk
EG0024 affected102 at risk
EG0036 affected143 at risk
EG0042 affected48 at risk
EG0054 affected144 at risk
EG0064 affected48 at risk
EG00717 affected144 at risk
EG0085 affected48 at risk
Tinea Capitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0010 affected298 at risk
EG0020 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0052 affected144 at risk
EG0061 affected48 at risk
EG0072 affected144 at risk
EG0083 affected48 at risk
Typhoid Fever
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected43 at risk
EG00114 affected298 at risk
EG0029 affected102 at risk
EG0030 affected143 at risk
EG0040 affected48 at risk
EG0051 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected43 at risk
EG00116 affected298 at risk
EG0028 affected102 at risk
EG0033 affected143 at risk
EG0041 affected48 at risk
EG0059 affected144 at risk
EG0064 affected48 at risk
EG00726 affected144 at risk
EG0089 affected48 at risk
Haemoglobin Decreased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected43 at risk
EG0017 affected298 at risk
EG0022 affected102 at risk
EG0038 affected143 at risk
EG0045 affected48 at risk
EG0053 affected144 at risk
EG0061 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0002 affected43 at risk
EG00116 affected298 at risk
EG0027 affected102 at risk
EG0031 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Headache
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0009 affected43 at risk
EG00140 affected298 at risk
EG00213 affected102 at risk
EG00314 affected143 at risk
EG0042 affected48 at risk
EG0054 affected144 at risk
EG0060 affected48 at risk
EG0070 affected144 at risk
EG0080 affected48 at risk
Pruritus Generalised
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected43 at risk
EG00115 affected298 at risk
EG0025 affected102 at risk
EG0033 affected143 at risk
EG0040 affected48 at risk
EG0050 affected144 at risk
EG0060 affected48 at risk
EG0071 affected144 at risk
EG0080 affected48 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will with hold such publication for up to an additional 60 days.
D018701
Mononegavirales Infections
27
BG00571
BG00622
BG00777
BG00827
BG009668
47
BG005144
BG00648
BG007144
BG00848
BG0091017
0
BG0050
BG0060
BG0070
BG0080
BG0090
0
BG0050
BG0060
BG0070
BG0080
BG0090
0
BG0050
BG0060
BG0070
BG0080
BG0090
47
BG005144
BG00647
BG007144
BG00848
BG0091014
1
BG0050
BG0061
BG0070
BG0080
BG0094
0
BG0050
BG0060
BG0070
BG0080
BG0090
0
BG0050
BG0060
BG0070
BG0080
BG0090
142
OG00446
OG005143
OG00648
OG007143
OG00848
21
OG0041
OG00522
OG0065
OG0077
OG0080
143
OG00448
OG005144
OG00648
OG007144
OG00848
52
OG00414
OG00545
OG00615
OG00736
OG00812
142
OG00446
OG005143
OG00648
OG007143
OG00848
26
OG0046
OG00527
OG0068
OG00723
OG00814
48
OG004144
OG00548
OG006144
OG00748
1
OG0045
OG0050
OG00615
OG0073
48
OG004144
OG00548
OG006144
OG00748
20
OG00460
OG00518
OG00688
OG00728
46
OG004143
OG00548
OG006143
OG00748
13
OG00446
OG00513
OG00692
OG00731
48
OG004144
OG00544
0
OG0041
OG0050
48
OG004144
OG00548
0
OG0040
OG0050
134
OG00446
OG005124
OG00643
OG007124
OG00838
OG0039929(8172 to 12064)
OG00474(48 to 114)
OG00510212(8419 to 12388)
OG00642(NA to 60)Here, 'NA' signifies that lower limit of calculated 95% CI was less than LLOQ.
OG00722568(18426 to 27642)
OG008NA(NA to 38)Here, 'NA' signifies that geometric mean and lower limit of calculated 95% CI was less than LLOQ.