Safety, Tolerability and Immunogenicity Study of 3 Prime-... | NCT02564523 | Trialant
NCT02564523
Sponsor
Janssen Vaccines & Prevention B.V.
Status
Completed
Last Update Posted
Mar 7, 2022Actual
Enrollment
1,075Actual
Phase
Phase 2
Conditions
Hemorrhagic Fever, Ebola
Interventions
Ad26.ZEBOV
MVA-BN-Filo
Placebo
Countries
Burkina Faso
Côte d’Ivoire
Kenya
Uganda
Protocol Section
Identification Module
NCT ID
NCT02564523
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR107249
Secondary IDs
ID
Type
Description
Link
VAC52150EBL2002
Other Identifier
Janssen Vaccines & Prevention B.V.
2019-000690-22
EudraCT Number
Brief Title
Safety, Tolerability and Immunogenicity Study of 3 Prime-boost Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo in Healthy Adults, Children and Human Immunodeficiency Virus Positive (HIV+) Adults
Official Title
A Randomized, Observer-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Different Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults, Including Elderly Subjects, HIV-infected Subjects, and Healthy Children in Two Age Strata in Africa
Acronym
Not provided
Organization
Janssen Vaccines & Prevention B.V.INDUSTRY
Status Module
Record Verification Date
Feb 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
Nov 6, 2015Actual
Primary Completion Date
Feb 12, 2019Actual
Completion Date
Feb 12, 2019Actual
First Submitted Date
Sep 29, 2015
First Submission Date that Met QC Criteria
Sep 29, 2015
First Posted Date
Sep 30, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 9, 2022
Results First Submitted that Met QC Criteria
Feb 9, 2022
Results First Posted Date
Mar 7, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 10, 2020
Certification/Extension First Submitted that Passed QC Review
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 to assess the safety, tolerability and immunogenicity of three heterologous prime-boost regimens for Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo. The study will include healthy adults and elderly participants, HIV infected participants and healthy children in 2 age strata.
Detailed Description
This is a randomized, observer-blind, placebo-controlled, parallel-group, multicenter, Phase 2 study evaluating the safety, tolerability and immunogenicity of 3 heterologous prime-boost regimens using Ad26.ZEBOV as prime and MVA-BN-Filo as boost vaccination, administered at 28-, 56- and 84-day (Group 1, 2 and 3 as above) intervals, in healthy adults and elderly participants. A 28- and 56-day (Groups 1 and 2, as above) schedule will be evaluated in HIV-infected participants and in healthy children in 2 age strata. The study consists of a screening phase of up to 8 weeks, a vaccination phase in which participants will be vaccinated at baseline (Day 1) followed by a boost vaccination on Day 29, 57 or 85, a post-vaccination phase and long-term follow-up phase until Day 365. Participants in Cohort 1 substudy (Group 1 and 2) who received Ad26.ZEBOV and MVA-BN-Filo (at selected sites) will receive Ad26.ZEBOV as third vaccination and who received placebo will receive placebo as third vaccination (at least 1 year post prime vaccination). All participants within a cohort will be followed in a blinded manner by the site until the last subject in that cohort has completed the study. This study will be conducted in Africa and the enrollment will take place sequentially in three cohorts: the first cohort will consist of healthy participants (18 - 70 years); the second cohort (2a) will include HIV-infected participants (18 to 50 years) and healthy children 12 to 17 years (cohort 2b); the third cohort will include children aged 4 to 11 years inclusive will be enrolled. Within each cohort, participants will be randomized in a 5:1 ratio to receive active vaccine versus placebo. Safety evaluations will include assessments of adverse events, an electrocardiogram (ECG) for adult participants at screening, physical examination, vital signs (blood pressure, pulse/heart rate, body temperature), clinical laboratory and pregnancy testing. An independent data monitoring committee (IDMC) will be established to monitor data on a regular basis to ensure the continuing safety of the participants enrolled in the study.
Conditions Module
Conditions
Hemorrhagic Fever, Ebola
Keywords
Healthy
Vaccine
Ebola viruses
Ebola virus disease (EVD)
Filoviruses
Hemorrhagic fever
Monovalent vaccine
Human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV)
Modified Vaccinia Virus Ankara - Bavarian Nordic (MVA-BN) Filo-vector
Safety
Immunogenicity
Inserm, Centre Muraz
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,075Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 1
Experimental
Participants will receive Ad26.ZEBOV, MVA-BN-Filo (Day 1/Day 29) or placebo (Day 1/Day 29) followed by a subset of participants who received Ad26.ZEBOV and MVA-BN-Filo (at selected sites) will receive Ad26.ZEBOV as third vaccination and who received placebo will receive placebo as third vaccination (at least 1 year post prime vaccination).
Biological: Ad26.ZEBOV
Biological: MVA-BN-Filo
Biological: Placebo
Group 2
Experimental
Participants will receive Ad26.ZEBOV, MVA-BN-Filo (Day 1/Day 57) or placebo (Day 1/Day 57) followed by a subset of participants who received Ad26.ZEBOV and MVA-BN-Filo (at selected sites) will receive Ad26.ZEBOV as third vaccination and who received placebo will receive placebo as third vaccination (at least 1 year post prime vaccination).
Biological: Ad26.ZEBOV
Biological: MVA-BN-Filo
Biological: Placebo
Group 3
Experimental
Participants will receive Ad26.ZEBOV, MVA-BN-Filo (Day 1/Day 85) or placebo (Day 1/Day 85)
Biological: Ad26.ZEBOV
Biological: MVA-BN-Filo
Biological: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ad26.ZEBOV
Biological
One 0.5 mL intramuscular (IM) injection of (5x10*10 viral particles)
Group 1
Group 2
Group 3
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events (Day 29)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Up to 28 days post-dose 1 (Day 29)
Number of Participants With Adverse Events (AEs) (28-Day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Up to 28 days post-dose 2 (Day 57 for Cohorts 1, 2a, 2b and 3 [28-Day Interval])
Number of Participants With Adverse Events (56-day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Up 28 days post-dose 2 (Day 85 for Cohorts 1, 2a, 2b and 3 [56-Day Interval])
Number of Participants With Adverse Events (84-day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Up to 28 days post-dose 2 (Day 113 for Cohort 1 [84-Day Interval])
Number of Participants With Adverse Events Post-dose 3 (Day 393)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Up 28 days post-dose 3 (Day 393)
Number of Participants With Serious Adverse Events
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Secondary Outcomes
Measure
Description
Time Frame
Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Filovirus Animal Non-Clinical Group (FANG) Enzyme-linked Immunosorbent Assay
GMCs of antibodies binding to EBOV GP using FANG ELISA were reported and were measured in ELISA unit per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using FANG 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:
Criteria for healthy adults and elderly participants:
Participant must be healthy in the investigator's clinical judgment on the basis of clinical laboratory tests, medical history, ECG, physical examination and vital signs performed at screening. Participants with hemoglobin values outside the local laboratory reference ranges may be included if the hemoglobin is above the age/gender specific limits
Female participants of childbearing potential must use adequate birth control measures, must have a negative pregnancy test at screening and immediately prior to each study vaccination
A man who is sexually active with a woman of childbearing potential must be willing to use condoms for sexual intercourse beginning prior to enrollment, unless a vasectomy was performed more than 1 year prior to screening
Participant must pass the test of understanding (TOU)
Participant must be available and willing to participate for the duration of the study visits and follow-up, provide verifiable identification, and have a means to be contacted Additional Inclusion Criteria HIV-infected Participants
Participant must be between 18 to 50 years of age and must have a documented HIV-infection for at least 6 months prior to screening
Participant must be on a stable 3 drug regimen of Highly Active Antiretroviral Therapy for at least 4 weeks prior to screening and having a CD4 positive cell count of >350 cells/microliter. Also participant must be in an otherwise reasonable good medical condition Additional Inclusion Criteria Children Participants
Parent/legal guardian must pass the TOU before signing the inform consent form. Informed assent must be obtained from adolescents and older children, depending on local regulations and practice
Pediatric participant's age on the day of randomization must be within one of the 2 age strata: 12-17 years or 4-11 years (all ages inclusive)
Pediatric participants must have received all routine immunizations appropriate for his or her age as reported by the parent(s)/legal guardian, according to local routine vaccination schedules
Exclusion criteria:
Diagnosed with Ebola virus disease or previously exposed to Ebola virus including travel to epidemic Ebola areas less than 1 month prior to screening
Having received any candidate Ebola vaccine or any experimental candidate Ad26- or MVA-based vaccine in the past
Having HIV type 1 or type 2 infection (for healthy adults/elderly/children)
Pediatric participants with weight-per-height below 10th percentile according to the Centers for Disease Control and Prevention (CDC) growth charts (4- to 11-year-olds)
A woman who is pregnant, breast-feeding or planning to become pregnant while enrolled in the study or within at least 3 months after the prime vaccination or up to 1 month after the boost vaccination (whichever takes longer) or within at least 3 months after the third vaccination
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.
A total of 1075 participants were enrolled. Among 1075 participants, 1 participant was enrolled twice and 1 participant was enrolled erroneously, but did not receive any study vaccination.
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5*10^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
May 4, 2017
Feb 9, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Ghana
Rwanda
Tanzania
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
MVA-BN-Filo
Biological
One 0.5 mL IM injection of (1x10*8 infectious units)
Group 1
Group 2
Group 3
Placebo
Biological
One 0.5 mL IM injection of 0.9% saline
Group 1
Group 2
Group 3
Up to 3 years and 3 months
Number of Participants With Immediate Reportable Events (IREs)
The following neuroinflammatory disorders were considered immediate reportable events which had to be reported to the sponsor within 24 hours of becoming aware of the event. Neuroinflammatory disorders included: cranial nerve disorders including paralyses/paresis (example: bell's palsy), optic neuritis, multiple sclerosis, transverse myelitis, guillain-barre syndrome including miller fisher syndrome, bickerstaff's encephalitis and other variants, acute disseminated encephalomyelitis, including site-specific variants (example: non-infectious encephalitis, encephalomyelitis, myelitis, myeloradiculomyelitis), myasthenia gravis and lambert-eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, including chronic inflammatory, demyelinating polyneuropathy, multifocal motor neuropathy, and polyneuropathies associated with monoclonal gammopathy, narcolepsy, isolated paresthesia of more than 7 days duration.
Up to 3 years and 3 months
Number of Participants With Solicited Local Adverse Events (Day 8)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
7 days post-dose 1 (Day 8)
Number of Participants With Solicited Local Adverse Events (28-day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Up to 7 days post-dose 2 (Day 36 for Cohort 1, 2a, 2b and 3 [28-Day Interval])
Number of Participants With Solicited Local Adverse Events Post-dose 2 (56-day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Up to 7 days post-dose 2 (Day 64 for Cohort 1, 2a, 2b and 3 [56-Day Interval])
Number of Participants With Solicited Local Adverse Events (84-day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Up to 7 days post-dose 2 (Day 92 for Cohort 1 [84-Day Interval])
Number of Participants With Solicited Local Adverse Events (Day 372)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Up 7 days post-dose 3 (Day 372)
Number of Participants With Solicited Systemic Adverse Events (Day 8)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Up to 7 days post-dose 1 (Day 8)
Number of Participants With Solicited Systemic Adverse Events (28-Day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Up to 7 days post-dose 2 (Day 36 for Cohorts 1, 2a, 2b and 3 [28-Day Interval])
Number of Participants With Solicited Systemic Adverse Events (56-Day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Up 7 days post-dose 2 (Day 64 for Cohort 1, 2a, 2b and 3 [56-Day Interval])
Number of Participants With Solicited Systemic Adverse Events (84-Day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Up 7 days post-dose 2 (Day 92 for Cohort 1 [84-Day Interval])
Number of Participants With Solicited Systemic Adverse Events (Day 372)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Up to 7 days post-dose 3 (Day 372)
21-days post-dose 2 (Day 50 for Cohorts 1, 2a, 2b, 3 [28-day interval] , Day 78 for Cohort 1, 2a, 2b, 3 [56-day interval] and Day 106 Cohort 1 [84-day interval]
Number of Participants With Serious Adverse Events Post-dose 3
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Up 28 days post-dose 3 (Day 393)
Ouagadougou
Burkina Faso
Abidjan
Côte d’Ivoire
Toupah/Ousrou
Côte d’Ivoire
Nairobi
Kenya
Entebbe
Uganda
Kampala
Uganda
Derived
Anywaine Z, Barry H, Anzala O, Mutua G, Sirima SB, Eholie S, Kibuuka H, Betard C, Richert L, Lacabaratz C, McElrath MJ, De Rosa SC, Cohen KW, Shukarev G, Katwere M, Robinson C, Gaddah A, Heerwegh D, Bockstal V, Luhn K, Leyssen M, Thiebaut R, Douoguih M; EBL2002 Study group. Safety and immunogenicity of 2-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccination in children and adolescents in Africa: A randomised, placebo-controlled, multicentre Phase II clinical trial. PLoS Med. 2022 Jan 11;19(1):e1003865. doi: 10.1371/journal.pmed.1003865. eCollection 2022 Jan.
Barry H, Mutua G, Kibuuka H, Anywaine Z, Sirima SB, Meda N, Anzala O, Eholie S, Betard C, Richert L, Lacabaratz C, McElrath MJ, De Rosa S, Cohen KW, Shukarev G, Robinson C, Gaddah A, Heerwegh D, Bockstal V, Luhn K, Leyssen M, Douoguih M, Thiebaut R; EBL2002 Study group. Safety and immunogenicity of 2-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccination in healthy and HIV-infected adults: A randomised, placebo-controlled Phase II clinical trial in Africa. PLoS Med. 2021 Oct 29;18(10):e1003813. doi: 10.1371/journal.pmed.1003813. eCollection 2021 Oct.
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 85.
FG005
Cohort 1: Placebo, Placebo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
Participants (human immunodeficiency virus [HIV]-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
FG007
Cohort 2a: Placebo, Placebo, 28-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
FG009
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
FG011
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants ((Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
FG013
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
FG015
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
FG017
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
FG000225 subjects
FG00143 subjects
FG002224 subjects
FG00344 subjects
FG004110 subjects
FG00522 subjects
FG00659 subjects
FG00712 subjects
FG00859 subjects
FG00912 subjects
FG01055 subjects
FG01111 subjects
FG01255 subjects
FG01310 subjects
FG01454 subjects
FG01512 subjects
FG01654 subjects
FG01712 subjects
Participants Who Received Booster Dose at 1 Year Post Dose 1 (on Day 365)
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5*10^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 85.
BG005
Cohort 1: Placebo, Placebo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
Participants (human immunodeficiency virus [HIV]-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
BG007
Cohort 2a: Placebo, Placebo, 28-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
BG009
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
BG011
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants ((Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
BG013
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
BG015
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
BG017
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
BG018
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000225
BG00143
BG002224
BG00344
BG004110
BG00522
BG00659
BG00712
BG00859
BG00912
BG01055
BG01111
BG01255
BG01310
BG01454
BG01512
BG01654
BG01712
BG0181073
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00033.3± 12.41
BG00132± 10.43
BG00233.3± 11.52
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00073
BG00115
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0003
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
BURKINA FASO
Title
Measurements
BG00076
BG00116
BG002
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
Number of Participants With Adverse Events (Day 29)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5*10^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 85.
OG005
Cohort 1: Placebo, Placebo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
Participants (human immunodeficiency virus [HIV]-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG007
Cohort 2a: Placebo, Placebo, 28-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG009
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG011
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants ((Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG013
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG015
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG017
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Units
Counts
Participants
OG000225
OG00143
OG002224
OG003
Title
Denominators
Categories
Title
Measurements
OG00096
OG00117
OG00268
OG003
Primary
Number of Participants With Adverse Events (AEs) (28-Day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Count of Participants
Participants
Up to 28 days post-dose 2 (Day 57 for Cohorts 1, 2a, 2b and 3 [28-Day Interval])
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5*10^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Primary
Number of Participants With Adverse Events (56-day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Count of Participants
Participants
Up 28 days post-dose 2 (Day 85 for Cohorts 1, 2a, 2b and 3 [56-Day Interval])
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Primary
Number of Participants With Adverse Events (84-day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Count of Participants
Participants
Up to 28 days post-dose 2 (Day 113 for Cohort 1 [84-Day Interval])
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 85.
OG001
Cohort 1: Placebo, Placebo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
Units
Counts
Participants
Primary
Number of Participants With Adverse Events Post-dose 3 (Day 393)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5*10^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Primary
Number of Participants With Serious Adverse Events
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5*10^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Primary
Number of Participants With Immediate Reportable Events (IREs)
The following neuroinflammatory disorders were considered immediate reportable events which had to be reported to the sponsor within 24 hours of becoming aware of the event. Neuroinflammatory disorders included: cranial nerve disorders including paralyses/paresis (example: bell's palsy), optic neuritis, multiple sclerosis, transverse myelitis, guillain-barre syndrome including miller fisher syndrome, bickerstaff's encephalitis and other variants, acute disseminated encephalomyelitis, including site-specific variants (example: non-infectious encephalitis, encephalomyelitis, myelitis, myeloradiculomyelitis), myasthenia gravis and lambert-eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, including chronic inflammatory, demyelinating polyneuropathy, multifocal motor neuropathy, and polyneuropathies associated with monoclonal gammopathy, narcolepsy, isolated paresthesia of more than 7 days duration.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5*10^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Primary
Number of Participants With Solicited Local Adverse Events (Day 8)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5*10^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Primary
Number of Participants With Solicited Local Adverse Events (28-day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Count of Participants
Participants
Up to 7 days post-dose 2 (Day 36 for Cohort 1, 2a, 2b and 3 [28-Day Interval])
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5*10^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Number of Participants With Solicited Local Adverse Events Post-dose 2 (56-day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Count of Participants
Participants
Up to 7 days post-dose 2 (Day 64 for Cohort 1, 2a, 2b and 3 [56-Day Interval])
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Number of Participants With Solicited Local Adverse Events (84-day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Count of Participants
Participants
Up to 7 days post-dose 2 (Day 92 for Cohort 1 [84-Day Interval])
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 85.
OG001
Cohort 1: Placebo, Placebo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
Primary
Number of Participants With Solicited Local Adverse Events (Day 372)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5*10^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Primary
Number of Participants With Solicited Systemic Adverse Events (Day 8)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5*10^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Primary
Number of Participants With Solicited Systemic Adverse Events (28-Day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Count of Participants
Participants
Up to 7 days post-dose 2 (Day 36 for Cohorts 1, 2a, 2b and 3 [28-Day Interval])
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5*10^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Number of Participants With Solicited Systemic Adverse Events (56-Day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Count of Participants
Participants
Up 7 days post-dose 2 (Day 64 for Cohort 1, 2a, 2b and 3 [56-Day Interval])
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Primary
Number of Participants With Solicited Systemic Adverse Events (84-Day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Posted
Count of Participants
Participants
Up 7 days post-dose 2 (Day 92 for Cohort 1 [84-Day Interval])
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 85.
OG001
Cohort 1: Placebo, Placebo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
Primary
Number of Participants With Solicited Systemic Adverse Events (Day 372)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5*10^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Secondary
Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Filovirus Animal Non-Clinical Group (FANG) Enzyme-linked Immunosorbent Assay
GMCs of antibodies binding to EBOV GP using FANG ELISA were reported and were measured in ELISA unit per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using FANG 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 (administered not more than 10 days outside the visit window), have immunogenicity data, from baseline and at least one post-vaccination evaluable immunogenicity sample, and have no major protocol violations influencing the immune response.
Posted
Geometric Mean
95% Confidence Interval
ELISA units/mL
21-days post-dose 2 (Day 50 for Cohorts 1, 2a, 2b, 3 [28-day interval] , Day 78 for Cohort 1, 2a, 2b, 3 [56-day interval] and Day 106 Cohort 1 [84-day interval]
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5*10^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Secondary
Number of Participants With Serious Adverse Events Post-dose 3
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5*10^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Time Frame
Up to 3 years and 3 months
Description
Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).
Participants (healthy adults and elderly) received intramuscular (IM) injection of Ad26.ZEBOV 5*10^10 viral particles (vp) on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 infectious units (Inf.U) on Day 29. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 85.
0
110
6
110
43
110
EG005
Cohort 1: Placebo, Placebo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
Participants (human immunodeficiency virus [HIV]-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
1
59
1
59
24
59
EG007
Cohort 2a: Placebo, Placebo, 28-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
0
59
1
59
28
59
EG009
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
1
55
1
55
29
55
EG011
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants ((Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
0
55
0
55
33
55
EG013
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
0
54
1
54
27
54
EG015
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
0
54
0
54
22
54
EG017
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
0
12
1
12
9
12
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Dolichocolon
Congenital, familial and genetic disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG0030 affected44 at risk
EG004
Meniere's Disease
Ear and labyrinth disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0011 affected43 at risk
EG0020 affected224 at risk
EG003
Cataract
Eye disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0021 affected224 at risk
EG003
Glaucoma
Eye disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Inguinal Hernia
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected225 at risk
EG0010 affected43 at risk
EG0021 affected224 at risk
EG003
Obstruction Gastric
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0021 affected224 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Malaria
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected225 at risk
EG0011 affected43 at risk
EG0023 affected224 at risk
EG003
Pulmonary Tuberculosis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Typhoid Fever
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Alcohol Poisoning
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Burns Second Degree
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Ligament Sprain
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Electrolyte Imbalance
Metabolism and nutrition disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0021 affected224 at risk
EG003
Abortion Spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected225 at risk
EG0010 affected43 at risk
EG0021 affected224 at risk
EG003
Anembryonic Gestation
Pregnancy, puerperium and perinatal conditions
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0021 affected224 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected225 at risk
EG0010 affected43 at risk
EG0021 affected224 at risk
EG0030 affected44 at risk
EG0040 affected110 at risk
EG0050 affected22 at risk
EG0060 affected59 at risk
EG0071 affected12 at risk
EG0081 affected59 at risk
EG0090 affected12 at risk
EG0101 affected55 at risk
EG0110 affected11 at risk
EG0121 affected55 at risk
EG0130 affected10 at risk
EG0143 affected54 at risk
EG0151 affected12 at risk
EG0161 affected54 at risk
EG0171 affected12 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected225 at risk
EG0011 affected43 at risk
EG0024 affected224 at risk
EG003
Microcytic Anaemia
Blood and lymphatic system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG00014 affected225 at risk
EG0011 affected43 at risk
EG0028 affected224 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Blepharitis
Eye disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Conjunctivitis Allergic
Eye disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Eye Pruritus
Eye disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Dental Caries
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0002 affected225 at risk
EG0011 affected43 at risk
EG0022 affected224 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0003 affected225 at risk
EG0010 affected43 at risk
EG0023 affected224 at risk
EG003
Food Poisoning
Gastrointestinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Chest Pain
General disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected225 at risk
EG0010 affected43 at risk
EG0022 affected224 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0003 affected225 at risk
EG0012 affected43 at risk
EG0024 affected224 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected225 at risk
EG0010 affected43 at risk
EG0022 affected224 at risk
EG003
Infection Parasitic
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0002 affected225 at risk
EG0011 affected43 at risk
EG0024 affected224 at risk
EG003
Malaria
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG00016 affected225 at risk
EG0012 affected43 at risk
EG00212 affected224 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0008 affected225 at risk
EG0014 affected43 at risk
EG00211 affected224 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0002 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0011 affected43 at risk
EG0021 affected224 at risk
EG003
Rhinitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0007 affected225 at risk
EG0010 affected43 at risk
EG0022 affected224 at risk
EG003
Sepsis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0003 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG00017 affected225 at risk
EG0011 affected43 at risk
EG00218 affected224 at risk
EG003
Vulvovaginal Candidiasis
Infections and infestations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Foot Fracture
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Ligament Sprain
Injury, poisoning and procedural complications
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0011 affected43 at risk
EG0021 affected224 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0002 affected225 at risk
EG0012 affected43 at risk
EG0022 affected224 at risk
EG003
Blood Potassium Decreased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0002 affected225 at risk
EG0010 affected43 at risk
EG0023 affected224 at risk
EG003
Blood Pressure Increased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Blood Sodium Decreased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0009 affected225 at risk
EG0010 affected43 at risk
EG0024 affected224 at risk
EG003
Blood Urea Decreased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0003 affected225 at risk
EG0010 affected43 at risk
EG0022 affected224 at risk
EG003
Monocyte Count Decreased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected225 at risk
EG0010 affected43 at risk
EG0021 affected224 at risk
EG003
Transaminases Increased
Investigations
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected225 at risk
EG0010 affected43 at risk
EG0021 affected224 at risk
EG003
Hypercreatininaemia
Metabolism and nutrition disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0002 affected225 at risk
EG0012 affected43 at risk
EG0020 affected224 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0003 affected225 at risk
EG0011 affected43 at risk
EG0025 affected224 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0005 affected225 at risk
EG0010 affected43 at risk
EG0025 affected224 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG00015 affected225 at risk
EG0014 affected43 at risk
EG0028 affected224 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Sciatica
Nervous system disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0003 affected225 at risk
EG0011 affected43 at risk
EG0021 affected224 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0001 affected225 at risk
EG0012 affected43 at risk
EG0024 affected224 at risk
EG003
Productive Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0021 affected224 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA Version 21.1
Non-systematic Assessment
EG0000 affected225 at risk
EG0010 affected43 at risk
EG0020 affected224 at risk
EG003
A total of 259 participants in Cohort 1 either did not receive dose 2 (N=52) or received dose 2 outside of their protocol-defined interval (N=207), mainly due to the study pause resulting in a reduced precision for the immunogenicity estimates in the Per Protocol Analysis Set.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
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.
Participants (human immunodeficiency virus [HIV]-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG003
Cohort 2a: Placebo, Placebo, 28-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG005
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG007
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG003
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants ((Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG005
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG007
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 85.
OG005
Cohort 1: Placebo, Placebo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
Participants (human immunodeficiency virus [HIV]-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG007
Cohort 2a: Placebo, Placebo, 28-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG009
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG011
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants ((Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG013
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG015
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG017
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 85.
OG005
Cohort 1: Placebo, Placebo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
Participants (human immunodeficiency virus [HIV]-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG007
Cohort 2a: Placebo, Placebo, 28-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG009
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG011
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants ((Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG013
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG015
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG017
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 85.
OG005
Cohort 1: Placebo, Placebo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
Participants (human immunodeficiency virus [HIV]-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG007
Cohort 2a: Placebo, Placebo, 28-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG009
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG011
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants ((Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG013
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG015
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG017
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Units
Counts
Participants
OG000225
OG00143
OG002224
OG00344
OG004110
OG00522
OG00659
OG00712
OG00859
OG00912
OG01055
OG01111
OG01255
OG01310
OG01454
OG01512
OG01654
OG01712
Title
Denominators
Categories
Title
Measurements
OG000123
OG00116
OG002121
OG00320
OG00463
OG00511
OG00634
OG0074
OG00835
OG0092
OG01026
OG0113
OG01230
OG0135
OG01426
OG0156
OG01629
OG0175
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Participants (human immunodeficiency virus [HIV]-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG003
Cohort 2a: Placebo, Placebo, 28-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG005
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG007
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Units
Counts
Participants
OG000219
OG00139
OG00258
OG00312
OG00455
OG00510
OG00654
OG00712
Title
Denominators
Categories
Title
Measurements
OG000126
OG0019
OG00226
OG0032
OG00429
OG0053
OG00622
OG0072
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG003
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants ((Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG005
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG007
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 85.
OG005
Cohort 1: Placebo, Placebo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
Participants (human immunodeficiency virus [HIV]-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG007
Cohort 2a: Placebo, Placebo, 28-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG009
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG011
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants ((Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG013
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG015
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG017
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Units
Counts
Participants
OG000225
OG00143
OG002224
OG00344
OG004110
OG00522
OG00659
OG00712
OG00859
OG00912
OG01055
OG01111
OG01255
OG01310
OG01454
OG01512
OG01654
OG01712
Title
Denominators
Categories
Title
Measurements
OG000146
OG00127
OG002140
OG00326
OG00475
OG00514
OG00644
OG0077
OG00836
OG0092
OG01029
OG0114
OG01230
OG0135
OG01424
OG0152
OG01623
OG0172
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Participants (human immunodeficiency virus [HIV]-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG003
Cohort 2a: Placebo, Placebo, 28-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG005
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG007
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG003
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants ((Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG005
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG007
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 percent (%) saline on Day 1 followed by IM injection of placebo 0.9 % saline on Day 29. Subset of participants who earlier received placebo(at selected sites), afterwards received IM injection of placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 85.
OG005
Cohort 1: Placebo, Placebo, 84-Day Interval
Participants (healthy adults and elderly) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 85.
Participants (human immunodeficiency virus [HIV]-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG007
Cohort 2a: Placebo, Placebo, 28-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (HIV-infected adults) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG009
Cohort 2a: Placebo, Placebo, 56-Day Interval
Participants (HIV-infected adults) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG011
Cohort 2b: Placebo, Placebo, 28-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants ((Healthy Adolescents [12-17 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG013
Cohort 2b: Placebo, Placebo, 56-Day Interval
Participants (Healthy Adolescents [12-17 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 29.
OG015
Cohort 3: Placebo, Placebo, 28-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 29.
Participants (Healthy Children [4-11 years]) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo 1*10^8 Inf.U on Day 57.
OG017
Cohort 3: Placebo, Placebo, 56-Day Interval
Participants (Healthy Children [4-11 years]) received IM injection of Placebo 0.9 % saline on Day 1 followed by IM injection of Placebo 0.9 % saline on Day 57.
Units
Counts
Participants
OG000225
OG00143
OG002224
OG00344
OG004110
OG00522
OG00659
OG00712
OG00859
OG00912
OG01055
OG01111
OG01255
OG01310
OG01454
OG01512
OG01654
OG01712
Title
Denominators
Categories
Day 50 (21 days post-dose 2)
ParticipantsOG000171
ParticipantsOG00130
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00658
ParticipantsOG00711
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG01053
ParticipantsOG01110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG01453
ParticipantsOG01512
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG0003085(2648 to 3594)
OG001NA(NA to NA)Here, "NA" signifies that the calculated Geometric mean and its 95% CI were less than LLOQ 36.11 ELISA units/mL).
Participants (healthy adults and elderly) received IM injection of Ad26.ZEBOV 5*10^10 vp on Day 1 followed by IM injection of MVA-BN-filo Inf.U on Day 57. Subset of participants who earlier received Ad26.ZEBOV and MVA-BN-Filo (at selected sites), afterwards received IM injection of Ad26.ZEBOV 5*10^10 vp as a booster dose at 1 year post dose 1 (Day 365).
Participants (healthy adults and elderly) received placebo 0.9% saline on Day 1 followed by IM injection of placebo 0.9% saline on Day 57. Subset of participants who earlier received Placebo (at selected sites), afterwards received IM injection of Placebo 0.9 % saline as a booster dose at 1 year post dose 1 (Day 365).
Units
Counts
Participants
OG00034
OG0018
OG00239
OG0039
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
0 affected
110 at risk
EG0050 affected22 at risk
EG0060 affected59 at risk
EG0070 affected12 at risk
EG0080 affected59 at risk
EG0090 affected12 at risk
EG0100 affected55 at risk
EG0110 affected11 at risk
EG0120 affected55 at risk
EG0130 affected10 at risk
EG0140 affected54 at risk
EG0150 affected12 at risk
EG0160 affected54 at risk
EG0170 affected12 at risk
0 affected
44 at risk
EG0040 affected110 at risk
EG0050 affected22 at risk
EG0060 affected59 at risk
EG0070 affected12 at risk
EG0080 affected59 at risk
EG0090 affected12 at risk
EG0100 affected55 at risk
EG0110 affected11 at risk
EG0120 affected55 at risk
EG0130 affected10 at risk
EG0140 affected54 at risk
EG0150 affected12 at risk
EG0160 affected54 at risk
EG0170 affected12 at risk
0 affected
44 at risk
EG0040 affected110 at risk
EG0050 affected22 at risk
EG0060 affected59 at risk
EG0070 affected12 at risk
EG0080 affected59 at risk
EG0090 affected12 at risk
EG0100 affected55 at risk
EG0110 affected11 at risk
EG0120 affected55 at risk
EG0130 affected10 at risk
EG0140 affected54 at risk
EG0150 affected12 at risk
EG0160 affected54 at risk
EG0170 affected12 at risk
0 affected
44 at risk
EG0040 affected110 at risk
EG0050 affected22 at risk
EG0060 affected59 at risk
EG0070 affected12 at risk
EG0080 affected59 at risk
EG0090 affected12 at risk
EG0100 affected55 at risk
EG0110 affected11 at risk
EG0120 affected55 at risk
EG0130 affected10 at risk
EG0140 affected54 at risk
EG0150 affected12 at risk
EG0160 affected54 at risk
EG0170 affected12 at risk
0 affected
44 at risk
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44 at risk
EG0040 affected110 at risk
EG0050 affected22 at risk
EG0060 affected59 at risk
EG0071 affected12 at risk
EG0080 affected59 at risk
EG0090 affected12 at risk
EG0100 affected55 at risk
EG0110 affected11 at risk
EG0120 affected55 at risk
EG0130 affected10 at risk
EG0140 affected54 at risk
EG0150 affected12 at risk
EG0160 affected54 at risk
EG0170 affected12 at risk
NA
(NA to 39)
Here, "NA" signifies that the calculated Geometric mean and its lower limit of 95% CI were less than LLOQ 36.11 ELISA units/mL).
OG0106993(5256 to 9303)
OG011NA(NA to 74)Here, "NA" signifies that the calculated Geometric mean and its lower limit of 95% CI were less than LLOQ 36.11 ELISA units/mL).
OG0148007(6321 to 10142)
OG015NA(NA to 82)Here, "NA" signifies that the calculated Geometric mean and its lower limit of 95% CI were less than LLOQ 36.11 ELISA units/mL).
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG00859
ParticipantsOG00912
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG01253
ParticipantsOG01310
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG01653
ParticipantsOG01711
Title
Measurements
OG0027518(6468 to 8740)
OG003NA(NA to 53)Here, "NA" signifies that the calculated Geometric mean and its lower limit of 95% CI were less than LLOQ 36.11 ELISA units/mL)
OG0085283(4094 to 6817)
OG009NA(NA to NA)Here, "NA" signifies that the calculated Geometric mean and its 95% CI were less than LLOQ 36.11 ELISA units/mL).
OG01213532(10732 to 17061)
OG01337(NA to 89)Here, "NA" signifies that the calculated Geometric mean and its lower limit of 95% CI were less than LLOQ 36.11 ELISA units/mL).
OG01617388(12973 to 23306)
OG017NA(NA to NA)Here, "NA" signifies that the calculated Geometric mean and its 95% CI were less than LLOQ 36.11 ELISA units/mL).
ParticipantsOG00427
ParticipantsOG0057
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG0047300(5116 to 10417)
OG005NA(NA to NA)Here, "NA" signifies that the calculated Geometric mean and its 95% CI were less than LLOQ 36.11 ELISA units/mL).