A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lot... | NCT04228783 | Trialant
NCT04228783
Sponsor
Janssen Vaccines & Prevention B.V.
Status
Completed
Last Update Posted
May 25, 2025Actual
Enrollment
974Actual
Phase
Phase 3
Conditions
Ebola
Interventions
Ad26.ZEBOV
MVA-BN-Filo
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04228783
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR108694
Secondary IDs
ID
Type
Description
Link
VAC52150EBL3004
Other Identifier
Janssen Vaccines & Prevention B.V.
Brief Title
A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN-Filo in Adult Participants
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Immunogenicity, Safety, Reactogenicity, and Consistency of a Heterologous 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN®-Filo in Adult Participants
Acronym
Not provided
Organization
Janssen Vaccines & Prevention B.V.INDUSTRY
Status Module
Record Verification Date
May 2025
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
Feb 18, 2020Actual
Primary Completion Date
Apr 25, 2022Actual
Completion Date
Apr 25, 2022Actual
First Submitted Date
Jan 10, 2020
First Submission Date that Met QC Criteria
Jan 10, 2020
First Posted Date
Jan 14, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Apr 24, 2023
Results First Submitted that Met QC Criteria
Apr 24, 2023
Results First Posted Date
May 17, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 22, 2025
Last Update Posted Date
May 25, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Vaccines & Prevention B.V.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to demonstrate that the paired 2-dose vaccine regimens from 3 consecutively manufactured lots of Adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 and 3 consecutively manufactured lots of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) including the ebola virus mayinga glycoprotein as Dose 2, administered at a 56-day interval, induce an equivalent humoral immune response.
Detailed Description
Not provided
Conditions Module
Conditions
Ebola
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
974Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Active Vaccine: Group 1 (Ad26.ZEBOV-Lot A, MVA-BN-Filo-Lot 1)
Experimental
Participants will receive Intramuscular injection (0.5 milliliter [mL]) of Adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5*10^10 viral particle(s) [vp], Lot A) on Day 1, followed by Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1*10^8 infectious unit(s) [Inf U], Lot 1) on Day 57.
Biological: Ad26.ZEBOV
Biological: MVA-BN-Filo
Active Vaccine: Group 2 (Ad26.ZEBOV-Lot B, MVA-BN-Filo-Lot 2)
Experimental
Participants will receive Intramuscular injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot B) on Day 1, followed by MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 2) on Day 57.
Biological: Ad26.ZEBOV
Biological: MVA-BN-Filo
Active Vaccine: Group 3 (Ad26.ZEBOV-Lot C, MVA-BN-Filo-Lot 3)
Experimental
Participants will receive Intramuscular injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot C) on Day 1, followed by MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 3) on Day 57.
Biological: Ad26.ZEBOV
Biological: MVA-BN-Filo
Control Vaccine: Group 4 (Placebo)
Placebo Comparator
Participants will receive Intramuscular injection (0.5 mL) of placebo (0.9 percent [%] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ad26.ZEBOV
Biological
Participants will receive IM injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot A, B, and C) on Day 1 (Groups 1, 2, 3 and 5) and an Ad26.ZEBOV booster dose on Day 177 (Group 5).
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against the Ebola Virus Glycoprotein (EBOV GP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 21 Days Post Vaccination 2
Antibody GMCs against the EBOV GP as measured by ELISA at 21 days post Vaccination 2 were reported. GMCs of antibodies binding to EBOV GP using ELISA were reported and were measured in ELISA units per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the lower limit of quantification (LLOQ) of 36.11 EU/mL were imputed with half of the LLOQ prior to the computation of the GMCs.
21 Days Post Vaccination 2 (Day 78)
Secondary Outcomes
Measure
Description
Time Frame
Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against the Ebola Virus Glycoprotein (EBOV GP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 56 Days Post Vaccination 1
Antibody GMCs against the EBOV GP as measured by ELISA at 56 days post Vaccination 1 were reported. GMCs of antibodies binding to EBOV GP using ELISA were reported and were measured in ELISA units per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the LLOQ of 36.11 EU/mL were imputed with half of the LLOQ prior to the computation of the GMCs.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Signed an informed consent form (ICF)
Medically stable in the investigator's clinical judgment on the basis of physical examination, medical history, and vital signs performed at screening
Before randomization, a woman must be either: a. Not of childbearing potential; b. Of childbearing potential and practicing an acceptable effective method of birth control and agrees to remain on such a method of birth control from signing the informed consent form (ICF) until at least 3 months post Dose 1 vaccination or 28 days post Dose 2 vaccination or 3 months post booster vaccination (Groups 5-6 only), whichever comes later. Use of hormonal contraception should start at least 28 days before the first administration of study vaccine. Acceptable effective methods for this study include: 1) hormonal contraception; 2) intrauterine device (IUD); 3) intrauterine hormone-releasing system (IUS); 4) male or female condom with or without spermicide; 5) cap, diaphragm, or sponge with a vaginal spermicide; 6) vasectomized partner (the vasectomized partner should be the sole partner for that participant); 7) sexual abstinence
Women of childbearing potential must have a negative urine Beta-human chorionic gonadotropin (Beta-hCG) pregnancy test at screening and immediately prior to each study vaccine administration
Available and willing to participate for the duration of the study and follow-up visit
Willing to provide verifiable identification
Exclusion Criteria:
Having received any candidate Ebola vaccine
Diagnosed with Ebola virus disease (EVD), or prior exposure to Ebola virus, including travel to an area with Ebola outbreak less than 1 month prior to screening (if applicable)
Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines), including known allergy to egg, egg products, and aminoglycosides
Presence of acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0ºCelcius on Day 1. Participants with such symptoms will be excluded from enrollment at that time but may be rescheduled for enrollment at a later date
Human immunodeficiency virus (HIV) type 1 or type 2 infection, based on the medical history reported by the participant
Pregnant, breast-feeding
History of an underlying clinically significant acute or chronic medical condition
A total of 974 participants were enrolled and randomized, of which 970 participants received the vaccination and were included in the analysis.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1)
Participants received 0.5 milliliter (mL) intramuscular injection of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5*10^10 viral particles [vp], Lot A) on Day 1, followed by intramuscular injection of modified vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1*10^8 infectious units [Inf U], Lot 1) on Day 57.
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
Not provided
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
Jun 15, 2020
Apr 24, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
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
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Biological: Placebo
Booster Cohort: Group 5 (Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV)
Experimental
Participants will receive Intramuscular injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5*10^10 vp, a single Lot) on Day 1, followed by MVA-BN-Filo as Dose 2 (1*10^8 Inf U, a single Lot) on Day 57 and a booster dose of Ad26.ZEBOV (at a dose of 5*10^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
Biological: Ad26.ZEBOV
Biological: MVA-BN-Filo
Booster Cohort: Group 6 (Placebo)
Placebo Comparator
Participants will receive Intramuscular injection (0.5 mL) of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by placebo matching to MVA-BN-Filo as Dose 2 on Day 57 and a booster dose of matching placebo on Day 177.
Biological: Placebo
Active Vaccine: Group 1 (Ad26.ZEBOV-Lot A, MVA-BN-Filo-Lot 1)
Active Vaccine: Group 2 (Ad26.ZEBOV-Lot B, MVA-BN-Filo-Lot 2)
Active Vaccine: Group 3 (Ad26.ZEBOV-Lot C, MVA-BN-Filo-Lot 3)
Booster Cohort: Group 5 (Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV)
MVA-BN-Filo
Biological
Participants will receive IM injection (0.5 mL) of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 1, 2, 3 and 5) on Day 57.
Active Vaccine: Group 1 (Ad26.ZEBOV-Lot A, MVA-BN-Filo-Lot 1)
Active Vaccine: Group 2 (Ad26.ZEBOV-Lot B, MVA-BN-Filo-Lot 2)
Active Vaccine: Group 3 (Ad26.ZEBOV-Lot C, MVA-BN-Filo-Lot 3)
Booster Cohort: Group 5 (Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV)
Placebo
Biological
Participants will receive IM injection (0.5 mL) of placebo (0.9 % saline) as Dose 1 on Day 1, followed by placebo as Dose 2 on Day 57 (Groups 4 and 6) and a booster of matching placebo on Day 177 (Group 6).
Booster Cohort: Group 6 (Placebo)
Control Vaccine: Group 4 (Placebo)
56 Days Post Vaccination 1 (Day 57)
Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination 1 and 2
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, pruritis at the vaccination site.
Until 7 Days after Vaccination 1 on Day 1 (Up to Day 8); Until 7 Days after Vaccination 2 on Day 57 (Up to Day 64)
Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination 1 and 2
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature greater than or equal to (>=) 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post vaccination 1 and 2 (day of vaccination and the subsequent 7 days), if feasible, for the following events: fatigue, headache, nausea, myalgia, arthralgia, chills, and fever.
Until 7 Days after Vaccination 1 on Day 1 (Up to Day 8); Until 7 Days after Vaccination 2 on Day 57 (Up to Day 64)
Number of Participants With Unsolicited Adverse Events (AEs) Until 28 Days After Vaccination 1 and 2
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.
Until 28 Days After Vaccination 1 on Day 1 (Up to Day 29); until 28 days after Vaccination 2 on Day 57 (Up to Day 85)
Number of Participants With Serious Adverse Events (SAEs)
SAE was any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Tempe
Arizona
85283
United States
Central Kentucky Research Associates, Inc.
Lexington
Kentucky
40509
United States
The Center For Pharmaceutical Research
Kansas City
Missouri
64114
United States
Clinical Research Consortium, an AMR company
Las Vegas
Nevada
89119
United States
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
Knoxville
Tennessee
37920
United States
Alliance for Multispeciality Research
Norfolk
Virginia
23502
United States
FG001
Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot B) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 2) on Day 57.
FG002
Ad26.ZEBOV(Lot C), MVA-BN-Filo (Lot 3) (Group 3)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot C) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 3) on Day 57.
FG003
Placebo, Placebo (Group 4)
Participants received 0.5 mL intramuscular injection of placebo (0.9 percent [%] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
FG004
Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV (Group 5)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, a single Lot) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, a single Lot) on Day 57 and an intramuscular injection of booster dose of Ad26.ZEBOV (at a dose of 5*10^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
FG005
Placebo, Placebo, Placebo (Group 6)
Participants received 0.5 mL intramuscular injection of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57, and intramuscular injection of placebo matching to Ad26.ZEBOV booster on Day 177.
FG000287 subjects
FG001288 subjects
FG002287 subjects
FG00348 subjects
FG00450 subjects
FG00510 subjects
COMPLETED
FG000239 subjects
FG001237 subjects
FG002236 subjects
FG00339 subjects
FG00433 subjects
FG0056 subjects
NOT COMPLETED
FG00048 subjects
FG00151 subjects
FG00251 subjects
FG0039 subjects
FG00417 subjects
FG0054 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG00036 subjects
FG00136 subjects
FG00228 subjects
FG0036 subjects
FG004
Physician Decision
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0006 subjects
FG00110 subjects
FG00219 subjects
FG0031 subjects
FG004
Other
FG0004 subjects
FG0013 subjects
FG0022 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1)
Participants received 0.5 milliliter (mL) intramuscular injection of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5*10^10 viral particles [vp], Lot A) on Day 1, followed by intramuscular injection of modified vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1*10^8 infectious units [Inf U], Lot 1) on Day 57.
BG001
Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot B) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 2) on Day 57.
BG002
Ad26.ZEBOV(Lot C), MVA-BN-Filo (Lot 3) (Group 3)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot C) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 3) on Day 57.
BG003
Placebo, Placebo (Group 4)
Participants received 0.5 mL intramuscular injection of placebo (0.9 percent [%] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
BG004
Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV (Group 5)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, a single Lot) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, a single Lot) on Day 57 and an intramuscular injection of booster dose of Ad26.ZEBOV (at a dose of 5*10^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
BG005
Placebo, Placebo, Placebo (Group 6)
Participants received 0.5 mL intramuscular injection of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57, and intramuscular injection of placebo matching to Ad26.ZEBOV booster on Day 177.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000287
BG001288
BG002287
BG00348
BG00450
BG00510
BG006970
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
BG00035.3± 9.32
BG00134.7± 9.12
BG00235.3± 8.96
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000159
BG001159
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00031
BG00125
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0004
BG0011
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
UNITED STATES
Title
Measurements
BG000287
BG001288
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
Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against the Ebola Virus Glycoprotein (EBOV GP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 21 Days Post Vaccination 2
Antibody GMCs against the EBOV GP as measured by ELISA at 21 days post Vaccination 2 were reported. GMCs of antibodies binding to EBOV GP using ELISA were reported and were measured in ELISA units per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the lower limit of quantification (LLOQ) of 36.11 EU/mL were imputed with half of the LLOQ prior to the computation of the GMCs.
Per protocol (PP) analysis set included all randomized (Group 1-4 only) and vaccinated participants, who received Dose 1 and Dose 2 vaccinations, and booster vaccination (Groups 5 and 6 only) (administered within protocol-defined window), had at least 1 post vaccination (after date of vaccination) evaluable immunogenicity sample, had no major protocol deviations influencing the immune response. N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
21 Days Post Vaccination 2 (Day 78)
ID
Title
Description
OG000
Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1)
Participants received 0.5 milliliter (mL) intramuscular injection of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5*10^10 viral particles [vp], Lot A) on Day 1, followed by intramuscular injection of modified vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1*10^8 infectious units [Inf U], Lot 1) on Day 57.
OG001
Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot B) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 2) on Day 57.
OG002
Ad26.ZEBOV(Lot C), MVA-BN-Filo (Lot 3) (Group 3)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot C) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 3) on Day 57.
OG003
Placebo, Placebo (Group 4)
Participants received 0.5 mL intramuscular injection of placebo (0.9 percent [%] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
OG004
Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV (Group 5)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, a single Lot) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, a single Lot) on Day 57 and an intramuscular injection of booster dose of Ad26.ZEBOV (at a dose of 5*10^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
Units
Counts
Participants
OG000163
OG001163
OG002149
OG003
Title
Denominators
Categories
Title
Measurements
OG00011077(9806 to 12514)
OG00112223(10665 to 14010)
OG00211818(10320 to 13534)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio of GMCs
0.9
2-Sided
95
0.8
1.1
Equivalence
An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.
OG000
OG002
Secondary
Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against the Ebola Virus Glycoprotein (EBOV GP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 56 Days Post Vaccination 1
Antibody GMCs against the EBOV GP as measured by ELISA at 56 days post Vaccination 1 were reported. GMCs of antibodies binding to EBOV GP using ELISA were reported and were measured in ELISA units per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the LLOQ of 36.11 EU/mL were imputed with half of the LLOQ prior to the computation of the GMCs.
PP analysis set included all randomized (Groups 1-4 only) and vaccinated participants, who received Dose 1 and Dose 2 vaccinations, and booster vaccination (Groups 5 and 6 only) (administered within protocol-defined window), had at least 1 post vaccination (after date of vaccination) evaluable immunogenicity sample, had no major protocol deviations influence the immune response. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
56 Days Post Vaccination 1 (Day 57)
ID
Title
Description
OG000
Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1)
Participants received 0.5 milliliter (mL) intramuscular injection of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5*10^10 viral particles [vp], Lot A) on Day 1, followed by intramuscular injection of modified vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1*10^8 infectious units [Inf U], Lot 1) on Day 57.
Secondary
Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination 1 and 2
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, pruritis at the vaccination site.
Full analysis set (FAS) included all participants with at least one study vaccine administration documented. Here, "n (number analyzed)" signifies number of participants who were analyzed at the specified timepoints.
Posted
Count of Participants
Participants
Until 7 Days after Vaccination 1 on Day 1 (Up to Day 8); Until 7 Days after Vaccination 2 on Day 57 (Up to Day 64)
ID
Title
Description
OG000
Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1)
Participants received 0.5 milliliter (mL) intramuscular injection of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5*10^10 viral particles [vp], Lot A) on Day 1, followed by intramuscular injection of modified vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1*10^8 infectious units [Inf U], Lot 1) on Day 57.
OG001
Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2)
Secondary
Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination 1 and 2
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature greater than or equal to (>=) 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post vaccination 1 and 2 (day of vaccination and the subsequent 7 days), if feasible, for the following events: fatigue, headache, nausea, myalgia, arthralgia, chills, and fever.
FAS included all participants with at least one study vaccine administration documented. Here, "n (number analyzed)" signifies number of participants who were analyzed at the specified timepoints.
Posted
Count of Participants
Participants
Until 7 Days after Vaccination 1 on Day 1 (Up to Day 8); Until 7 Days after Vaccination 2 on Day 57 (Up to Day 64)
ID
Title
Description
OG000
Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1)
Participants received 0.5 milliliter (mL) intramuscular injection of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5*10^10 viral particles [vp], Lot A) on Day 1, followed by intramuscular injection of modified vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1*10^8 infectious units [Inf U], Lot 1) on Day 57.
Secondary
Number of Participants With Unsolicited Adverse Events (AEs) Until 28 Days After Vaccination 1 and 2
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.
FAS included all participants with at least one study vaccine administration documented. Here, "n (number analyzed)" signifies number of participants who were analyzed at the specified timepoints.
Posted
Count of Participants
Participants
Until 28 Days After Vaccination 1 on Day 1 (Up to Day 29); until 28 days after Vaccination 2 on Day 57 (Up to Day 85)
ID
Title
Description
OG000
Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1)
Participants received 0.5 milliliter (mL) intramuscular injection of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5*10^10 viral particles [vp], Lot A) on Day 1, followed by intramuscular injection of modified vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1*10^8 infectious units [Inf U], Lot 1) on Day 57.
OG001
Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot B) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 2) on Day 57.
Secondary
Number of Participants With Serious Adverse Events (SAEs)
SAE was any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
FAS included all participants with at least one study vaccine administration documented.
Posted
Count of Participants
Participants
Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
ID
Title
Description
OG000
Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1)
Participants received 0.5 milliliter (mL) intramuscular injection of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5*10^10 viral particles [vp], Lot A) on Day 1, followed by intramuscular injection of modified vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1*10^8 infectious units [Inf U], Lot 1) on Day 57.
OG001
Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot B) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 2) on Day 57.
Time Frame
Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6
Description
Full analysis set (FAS) included all participants with at least one study vaccine administration documented.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1)
Participants received 0.5 milliliter (mL) intramuscular injection of adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5*10^10 viral particles [vp], Lot A) on Day 1, followed by intramuscular injection of modified vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1*10^8 infectious units [Inf U], Lot 1) on Day 57.
0
287
4
287
0
287
EG001
Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot B) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 2) on Day 57.
0
288
1
288
0
288
EG002
Ad26.ZEBOV(Lot C), MVA-BN-Filo (Lot 3) (Group 3)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot C) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 3) on Day 57.
0
287
6
287
0
287
EG003
Placebo, Placebo (Group 4)
Participants received 0.5 mL intramuscular injection of placebo (0.9 percent [%] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
0
48
1
48
0
48
EG004
Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV (Group 5)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, a single Lot) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, a single Lot) on Day 57 and an intramuscular injection of booster dose of Ad26.ZEBOV (at a dose of 5*10^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
1
50
3
50
2
50
EG005
Placebo, Placebo, Placebo (Group 6)
Participants received 0.5 mL intramuscular injection of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57, and intramuscular injection of placebo matching to Ad26.ZEBOV booster on Day 177.
0
10
1
10
2
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Chest Pain
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected287 at risk
EG0010 affected288 at risk
EG0020 affected287 at risk
EG0030 affected48 at risk
EG0040 affected50 at risk
EG0050 affected10 at risk
Appendicitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected287 at risk
EG0011 affected288 at risk
EG0020 affected287 at risk
EG003
Ophthalmic Herpes Zoster
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected287 at risk
EG0010 affected288 at risk
EG0020 affected287 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected287 at risk
EG0010 affected288 at risk
EG0020 affected287 at risk
EG003
Fracture Displacement
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected287 at risk
EG0010 affected288 at risk
EG0020 affected287 at risk
EG003
Gun Shot Wound
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected287 at risk
EG0010 affected288 at risk
EG0020 affected287 at risk
EG003
Multiple Injuries
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected287 at risk
EG0010 affected288 at risk
EG0021 affected287 at risk
EG003
Rib Fracture
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected287 at risk
EG0010 affected288 at risk
EG0020 affected287 at risk
EG003
Road Traffic Accident
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected287 at risk
EG0010 affected288 at risk
EG0021 affected287 at risk
EG003
Stab Wound
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected287 at risk
EG0010 affected288 at risk
EG0020 affected287 at risk
EG003
Upper Limb Fracture
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected287 at risk
EG0010 affected288 at risk
EG0020 affected287 at risk
EG003
Venomous Bite
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected287 at risk
EG0010 affected288 at risk
EG0021 affected287 at risk
EG003
Alcoholic Seizure
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected287 at risk
EG0010 affected288 at risk
EG0021 affected287 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected287 at risk
EG0010 affected288 at risk
EG0020 affected287 at risk
EG003
Abortion Spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected287 at risk
EG0010 affected288 at risk
EG0021 affected287 at risk
EG003
Alcohol Withdrawal Syndrome
Psychiatric disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected287 at risk
EG0010 affected288 at risk
EG0021 affected287 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected287 at risk
EG0010 affected288 at risk
EG0020 affected287 at risk
EG003
Accelerated Hypertension
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected287 at risk
EG0010 affected288 at risk
EG0020 affected287 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected287 at risk
EG0010 affected288 at risk
EG0021 affected287 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Covid-19
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected287 at risk
EG0010 affected288 at risk
EG0020 affected287 at risk
EG0030 affected48 at risk
EG0042 affected50 at risk
EG0051 affected10 at risk
Ligament Sprain
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected287 at risk
EG0010 affected288 at risk
EG0020 affected287 at risk
EG003
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. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Participants received 0.5 mL intramuscular injection of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57, and intramuscular injection of placebo matching to Ad26.ZEBOV booster on Day 177.
27
OG00434
OG0054
NA
(NA to NA)
Here, 'NA' signifies that geometric mean and lower and upper limit of 95% CI was less than LLOQ.
OG00418877(14173 to 25142)
OG005NA(NA to NA)Here, 'NA' signifies that geometric mean and lower and upper limit of 95% CI was less than LLOQ.
Ratio of GMCs
0.9
2-Sided
95
0.8
1.1
Equivalence
An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.
OG001
OG002
Ratio of GMCs
1.0
2-Sided
95
0.9
1.2
Equivalence
An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.
OG001
Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot B) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 2) on Day 57.
OG002
Ad26.ZEBOV(Lot C), MVA-BN-Filo (Lot 3) (Group 3)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot C) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 3) on Day 57.
OG003
Placebo, Placebo (Group 4)
Participants received 0.5 mL intramuscular injection of placebo (0.9 percent [%] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
OG004
Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV (Group 5)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, a single Lot) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, a single Lot) on Day 57 and an intramuscular injection of booster dose of Ad26.ZEBOV (at a dose of 5*10^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
OG005
Placebo, Placebo, Placebo (Group 6)
Participants received 0.5 mL intramuscular injection of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57, and intramuscular injection of placebo matching to Ad26.ZEBOV booster on Day 177.
Units
Counts
Participants
OG000175
OG001177
OG002166
OG00329
OG00439
OG0056
Title
Denominators
Categories
Title
Measurements
OG000988(842 to 1159)
OG001994(865 to 1142)
OG002960(819 to 1126)
OG003NA(NA to NA)Here, 'NA' signifies that geometric mean and lower and upper limit of 95% CI was less than LLOQ.
OG0041023(773 to 1354)
OG005NA(NA to 37)Here, 'NA' signifies that geometric mean and lower limit of 95% CI was less than LLOQ.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio of GMCs
1.0
2-Sided
95
0.8
1.2
Equivalence
An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.
OG000
OG002
Ratio of GMCs
1.0
2-Sided
95
0.8
1.3
Equivalence
An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.
OG001
OG002
Ratio of GMCs
1.0
2-Sided
95
0.8
1.3
Equivalence
An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot B) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 2) on Day 57.
OG002
Ad26.ZEBOV(Lot C), MVA-BN-Filo (Lot 3) (Group 3)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot C) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 3) on Day 57.
OG003
Placebo, Placebo (Group 4)
Participants received 0.5 mL intramuscular injection of placebo (0.9 percent [%] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
OG004
Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV (Group 5)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, a single Lot) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, a single Lot) on Day 57 and an intramuscular injection of booster dose of Ad26.ZEBOV (at a dose of 5*10^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
OG005
Placebo, Placebo, Placebo (Group 6)
Participants received 0.5 mL intramuscular injection of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57, and intramuscular injection of placebo matching to Ad26.ZEBOV booster on Day 177.
Units
Counts
Participants
OG000287
OG001288
OG002287
OG00348
OG00450
OG00510
Title
Denominators
Categories
Until 7 days after Vaccination 1
ParticipantsOG000287
ParticipantsOG001288
ParticipantsOG002287
ParticipantsOG00348
ParticipantsOG00450
ParticipantsOG00510
Title
Measurements
OG000169
OG001176
OG002178
OG003
Until 7 days after Vaccination 2
ParticipantsOG000253
ParticipantsOG001253
ParticipantsOG002250
ParticipantsOG00343
OG001
Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot B) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 2) on Day 57.
OG002
Ad26.ZEBOV(Lot C), MVA-BN-Filo (Lot 3) (Group 3)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot C) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 3) on Day 57.
OG003
Placebo, Placebo (Group 4)
Participants received 0.5 mL intramuscular injection of placebo (0.9 percent [%] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
OG004
Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV (Group 5)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, a single Lot) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, a single Lot) on Day 57 and an intramuscular injection of booster dose of Ad26.ZEBOV (at a dose of 5*10^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
OG005
Placebo, Placebo, Placebo (Group 6)
Participants received 0.5 mL intramuscular injection of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57, and intramuscular injection of placebo matching to Ad26.ZEBOV booster on Day 177.
Units
Counts
Participants
OG000287
OG001288
OG002287
OG00348
OG00450
OG00510
Title
Denominators
Categories
Until 7 days after Vaccination 1
ParticipantsOG000287
ParticipantsOG001288
ParticipantsOG002287
ParticipantsOG00348
ParticipantsOG00450
ParticipantsOG00510
Title
Measurements
OG000162
OG001144
OG002156
OG003
Until 7 days after Vaccination 2
ParticipantsOG000253
ParticipantsOG001253
ParticipantsOG002250
ParticipantsOG00343
OG002
Ad26.ZEBOV(Lot C), MVA-BN-Filo (Lot 3) (Group 3)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot C) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 3) on Day 57.
OG003
Placebo, Placebo (Group 4)
Participants received 0.5 mL intramuscular injection of placebo (0.9 percent [%] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
OG004
Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV (Group 5)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, a single Lot) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, a single Lot) on Day 57 and an intramuscular injection of booster dose of Ad26.ZEBOV (at a dose of 5*10^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
OG005
Placebo, Placebo, Placebo (Group 6)
Participants received 0.5 mL intramuscular injection of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57, and intramuscular injection of placebo matching to Ad26.ZEBOV booster on Day 177.
Units
Counts
Participants
OG000287
OG001288
OG002287
OG00348
OG00450
OG00510
Title
Denominators
Categories
Until 28 days after Vaccination 1
ParticipantsOG000287
ParticipantsOG001288
ParticipantsOG002287
ParticipantsOG00348
ParticipantsOG00450
ParticipantsOG00510
Title
Measurements
OG00028
OG00125
OG00226
OG003
Until 28 days after Vaccination 2
ParticipantsOG000253
ParticipantsOG001253
ParticipantsOG002250
ParticipantsOG00343
OG002
Ad26.ZEBOV(Lot C), MVA-BN-Filo (Lot 3) (Group 3)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, Lot C) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, Lot 3) on Day 57.
OG003
Placebo, Placebo (Group 4)
Participants received 0.5 mL intramuscular injection of placebo (0.9 percent [%] saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57.
OG004
Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV (Group 5)
Participants received 0.5 mL intramuscular injection of Ad26.ZEBOV as Dose 1 (5*10^10 vp, a single Lot) on Day 1, followed by intramuscular injection of MVA-BN-Filo as Dose 2 (1*10^8 Inf U, a single Lot) on Day 57 and an intramuscular injection of booster dose of Ad26.ZEBOV (at a dose of 5*10^10 vp, a single Lot) 4 months after Dose 2 (on Day 177).
OG005
Placebo, Placebo, Placebo (Group 6)
Participants received 0.5 mL intramuscular injection of placebo (0.9% saline) matching to Ad26.ZEBOV as Dose 1 on Day 1, followed by intramuscular injection of placebo matching to MVA-BN-Filo as Dose 2 on Day 57, and intramuscular injection of placebo matching to Ad26.ZEBOV booster on Day 177.