A Study to Evaluate Dose Levels of Ad26.COV2.S Administer... | NCT04908722 | Trialant
NCT04908722
Sponsor
Janssen Vaccines & Prevention B.V.
Status
Completed
Last Update Posted
Feb 4, 2025Actual
Enrollment
1,609Actual
Phase
Phase 3
Conditions
COVID-19 Prevention
Interventions
Ad26.COV2.S
Countries
United States
Brazil
Germany
Poland
South Africa
Protocol Section
Identification Module
NCT ID
NCT04908722
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR108960
Secondary IDs
ID
Type
Description
Link
2020-005801-14
EudraCT Number
VAC31518COV3003
Other Identifier
Janssen Vaccines & Prevention B.V.
Brief Title
A Study to Evaluate Dose Levels of Ad26.COV2.S Administered as a Two-dose Schedule in Healthy Adults
Official Title
A Randomized, Double-blind, Phase 3 Study to Evaluate 6 Dose Levels of Ad26.COV2.S Administered As a Two-Dose Schedule in Healthy Adults
Acronym
Not provided
Organization
Janssen Vaccines & Prevention B.V.INDUSTRY
Status Module
Record Verification Date
Jan 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
YesNCT04817657No longer available
Start Date
Jun 18, 2021Actual
Primary Completion Date
Jul 10, 2023Actual
Completion Date
Jul 10, 2023Actual
First Submitted Date
May 27, 2021
First Submission Date that Met QC Criteria
May 27, 2021
First Posted Date
Jun 1, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Jan 22, 2024
Results First Submitted that Met QC Criteria
Apr 26, 2024
Results First Posted Date
May 23, 2024Actual
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
Jan 31, 2025
Last Update Posted Date
Feb 4, 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)
Yes
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
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to demonstrate non-inferiority (NI) in terms of humoral immune responses after 6 dose levels of Ad26.COV2.S.
Detailed Description
Not provided
Conditions Module
Conditions
COVID-19 Prevention
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
1,609Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 1: Ad26.COV2.S Dose Level 1
Experimental
Participants in the main study and sub study will receive intramuscular (IM) injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 1 on Days 1 and 57.
Biological: Ad26.COV2.S
Group 2: Ad26.COV2.S Dose Level 2
Experimental
Participants will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 2 on Days 1 and 57 in the main study.
Biological: Ad26.COV2.S
Group 3: Ad26.COV2.S Dose Level 3
Experimental
Participants in the main study and sub study will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 3 on Days 1 and 57.
Biological: Ad26.COV2.S
Group 4: Ad26.COV2.S Dose Level 4
Experimental
Participants will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 4 on Days 1 and 57 in the main study.
Biological: Ad26.COV2.S
Group 5: Ad26.COV2.S Dose Level 5
Experimental
Participants in the main study and sub study will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 5 on Days 1 and 57.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ad26.COV2.S
Biological
Participants will receive intramuscular (IM) injections of Ad26.COV2.S.
Group 1: Ad26.COV2.S Dose Level 1
Group 2: Ad26.COV2.S Dose Level 2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination
Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
28 days after first vaccination (at Day 29)
Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 14 Days After Second Vaccination
Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
14 days after second vaccination (at Day 71)
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA
Percentage of participants with serological response to vaccination to SARS-COV-2 S protein as measured by ELISA were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) the baseline (pre-dose 1) sample value was less than or equal to (<=) lower limit of quantification (LLOQ) and the post-baseline sample was greater than (>) LLOQ; (2) the baseline sample (pre-dose 1) value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>=4-fold) increase from the baseline sample value. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study
Participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening. Participant may have underlying illnesses, as long as the symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe Coronavirus disease 2019 (COVID-19), except for smoking, which is allowed. If on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participant will be included on the basis of physical examination, medical history, and vital signs
All female participants of childbearing potential must: a) have a negative highly sensitive urine pregnancy test at screening; b) have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration
Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine
Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
Exclusion Criteria:
Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius (C) (100.4 degree Fahrenheit [F]) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor
Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
Participant received or plans to receive: (a) licensed live attenuated vaccines - within 28 days before or after planned administration of the first or subsequent study vaccinations; and (b) other licensed (not live) vaccines - within 14 days before or after planned administration of the first or subsequent study vaccinations
Participant received an investigational drug (including investigational drugs for prophylaxis of COVID-19) or used an invasive investigational medical device within 30 days or received investigational immunoglobulin (Ig) or monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine within 6 months before the planned administration of the first dose of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study
Participant previously received a coronavirus vaccine
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
55 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Janssen Vaccines & Prevention B.V. Clinical Trial
Janssen Vaccines & Prevention B.V.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Baptist Health Center For Clinical Research
Little Rock
Arkansas
72205
United States
Anaheim Clinical Trials, LLC
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
As planned, the Participant flow, baseline characteristics, Outcome measures data and adverse events data were analyzed and reported combined for the main study and sub-study.
Recruitment Details
A total of 1609 participants were enrolled, but 1 participant was randomized by error. This participant was never treated and was removed from the randomized list.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group 1: Ad26.COV2.S 9x10^10 vp
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10^10 viral particles (vp) on Days 1 and 57.
FG001
Group 2: Ad26.COV2.S 7x10^10 vp
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Randomized Participants
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
2
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
Sep 16, 2022
Jan 22, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
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: Ad26.COV2.S
Group 6: Ad26.COV2.S Dose Level 6
Experimental
Participants in the main study and sub study will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 6 on Days 1 and 57.
Biological: Ad26.COV2.S
Group 3: Ad26.COV2.S Dose Level 3
Group 4: Ad26.COV2.S Dose Level 4
Group 5: Ad26.COV2.S Dose Level 5
Group 6: Ad26.COV2.S Dose Level 6
JNJ-78436735
Ad26COVS1
VAC31518
Day 29, Day 57, Day 71, Week 32, and Week 60
Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA
Geometric mean concentration of SARS-CoV-2 S protein binding antibody measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Day 29, Day 57, Day 71, Week 32, and Week 60
Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination
An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participant in their e-diary for 7 days after each vaccination. Solicited local AEs included injection site pain/tenderness, erythema and swelling at the study vaccine injection site. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
7 days after each vaccination (first vaccination [at Day 8], second vaccination [at Day 64])
Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination
An AE was any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) were noted in the subject diary after 7 days of each vaccination. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
7 days after each vaccination (first vaccination [at Day 8], second vaccination [at Day 64])
Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination
Unsolicited AEs were all AEs for which the subject was not specifically questioned in the subject diary. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
28 days after each vaccination (first vaccination [at Day 29], second vaccination [at Day 85])
Number of Participants With Serious Adverse Events (SAEs)
SAE was any untoward medical occurrence that at any dose may results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Number of Participants With Adverse Events of Special Interest (AESIs)
AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with thrombocytopenia syndrome were considered to be an AESI. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Number of Participants With AEs Leading to Study Discontinuation
Number of participants with AEs leading to study discontinuation were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Up to 60 weeks
Number of Participants With Medically-Attended Adverse Events (MAAEs)
MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
6 months after second vaccination (up to 32 weeks)
Anaheim
California
92801
United States
Ark Clinical Research
Long Beach
California
90815
United States
Paradigm Clinical Research Centers, Inc.
Redding
California
96001
United States
Wr McCr Llc
San Diego
California
92120
United States
Ark Clinical Research
Tustin
California
92780
United States
Velocity Clinical Research, Hallandale Beach
Hallandale
Florida
33009
United States
Floridian Research Institute
Miami
Florida
33179
United States
Medpharmics, LLC
Metairie
Louisiana
70006
United States
Clinical Research Center of Nevada
Las Vegas
Nevada
89106
United States
Rochester Clinical Research, Inc
Rochester
New York
14609
United States
Wake Research Associates
Raleigh
North Carolina
27612
United States
Trial Management Associates, LLC
Wilmington
North Carolina
28403
United States
Tekton Research Inc.
Yukon
Oklahoma
73099
United States
Coastal Carolina Research Center
North Charleston
South Carolina
29405
United States
Ventavia Research Group, LLC
Keller
Texas
76248
United States
Research Your Health
Plano
Texas
75093
United States
Clinical Research Partners, LLC
Richmond
Virginia
23226
United States
Universidade Federal De Minas Gerais - Hospital das ClÃnicas
Belo Horizonte
30130-100
Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte
30150-221
Brazil
CECOR Centro OncolOgico de Roraima
Boa Vista
69304-415
Brazil
Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
Campinas
13060-904
Brazil
Núcleo de Medicina Tropical - Universidade Federal do Ceará
Ceará
60430-160
Brazil
Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose
Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
Ribeirão Preto
14048-900
Brazil
Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu
Rio de Janeiro
26030-380
Brazil
CPQuali Pesquisa Clinica LTDA ME
São Paulo
01228-000
Brazil
Centro de Referencia E Treinamento Dst/Aids
São Paulo
04121-000
Brazil
Klinische Forschung Berlin-Mitte GmbH
Berlin
10787
Germany
Clinical Research HamburggmbH
Hamburg
22143
Germany
Klinische Forschung Hannover-Mitte GmbH
Hanover
30159
Germany
Synexus Clinical Research GmbH
Leipzig
04103
Germany
Universitaetsmedizin Rostock
Rostock
18057
Germany
Gdanskie Centrum Zdrowia
Gdansk
80-542
Poland
Centrum Medyczne Medyk
Rzeszów
35-055
Poland
Centrum Medyczne Pratia Poznan
Skorzewo
60 185
Poland
Synexus Helderberg Clinical Research Centre
Cape Town
7130
South Africa
Ndlovu Elandsdoorn Site
Dennilton
0485
South Africa
Stanza Clinical Research Centre : Mamelodi
Mamelodi East
122
South Africa
PHOENIX PHARMA (Pty) Ltd
Port Elizabeth
6001
South Africa
Gct Sunnyside
Pretoria
0002
South Africa
Setshaba Research Centre
Soshanguve
152
South Africa
Participants in the main study received IM injection of Ad26.COV2.S 7x10^10 vp on Days 1 and 57.
FG002
Group 3: Ad26.COV2.S 5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10^10 vp on Days 1 and 57.
FG003
Group 4: Ad26.COV2.S 3.5x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10^10 vp on Days 1 and 57.
FG004
Group 5: Ad26.COV2.S 2.5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10^10 vp on Days 1 and 57.
FG005
Group 6: Ad26.COV2.S 1.25x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10^10 vp on Days 1 and 57.
FG000291 subjects
FG001222 subjects
FG002293 subjects
FG003222 subjects
FG004291 subjects
FG005289 subjects
Main Study
FG000222 subjects
FG001222 subjectsParticipants in Group 2 were not enrolled in the sub-study.
FG002223 subjects
FG003222 subjectsParticipants in Group 4 were not enrolled in the sub-study.
FG004222 subjects
FG005221 subjects
Sub Study
FG00069 subjects
FG0010 subjectsParticipants in Group 2 were not enrolled in the sub-study.
FG00270 subjects
FG0030 subjectsParticipants in Group 4 were not enrolled in the sub-study.
FG00469 subjects
FG00568 subjects
Treated
Vaccinated Participants
FG000288 subjects
FG001221 subjects
FG002291 subjects
FG003220 subjects
FG004288 subjects
FG005285 subjects
Per Protocol Immunogenicity Set
FG000276 subjects
FG001212 subjects
FG002282 subjects
FG003212 subjects
FG004277 subjects
FG005271 subjects
COMPLETED
FG000237 subjects
FG001178 subjects
FG002244 subjects
FG003179 subjects
FG004240 subjects
FG005233 subjects
NOT COMPLETED
FG00054 subjects
FG00144 subjects
FG00249 subjects
FG00343 subjects
FG00451 subjects
FG00556 subjects
Type
Comment
Reasons
Protocol deviation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
Lost to Follow-up
FG00033 subjects
FG00133 subjects
FG00236 subjects
FG00330 subjects
FG004
Physician Decision
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG00012 subjects
FG0018 subjects
FG0027 subjects
FG0036 subjects
FG004
Other
FG0003 subjects
FG0011 subjects
FG0023 subjects
FG0032 subjects
FG004
Initiated prohibited medication
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Randomized but not vaccinated
FG0003 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG004
Full analysis set included all participants with at least one vaccine administration documented.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group 1: Ad26.COV2.S 9x10^10 vp
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10^10 viral particles (vp) on Days 1 and 57.
BG001
Group 2: Ad26.COV2.S 7x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 7x10^10 vp on Days 1 and 57.
BG002
Group 3: Ad26.COV2.S 5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10^10 vp on Days 1 and 57.
BG003
Group 4: Ad26.COV2.S 3.5x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10^10 vp on Days 1 and 57.
BG004
Group 5: Ad26.COV2.S 2.5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10^10 vp on Days 1 and 57.
BG005
Group 6: Ad26.COV2.S 1.25x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10^10 vp on Days 1 and 57.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000288
BG001221
BG002291
BG003220
BG004288
BG005285
BG0061593
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
BG00035.6± 10.21
BG00135.2± 9.87
BG00234.8± 9.82
BG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Adults (18-64 years)
Title
Measurements
BG000288
BG001221
BG002
Sex/Gender, Customized
Count of Participants
Participants
Title
Denominators
Categories
Female
Title
Measurements
BG000117
BG00173
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG000132
BG00183
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0011
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
Brazil
Title
Measurements
BG000155
BG001112
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 Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination
Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
The per protocol immunogenicity set included all randomized and vaccinated participants for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of participants analysed) signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
ELISA Units per millilitre (EU/mL)
28 days after first vaccination (at Day 29)
ID
Title
Description
OG000
Group 1: Ad26.COV2.S 9x10^10 vp
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10^10 viral particles (vp) on Days 1 and 57.
OG001
Group 2: Ad26.COV2.S 7x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 7x10^10 vp on Days 1 and 57.
OG002
Group 3: Ad26.COV2.S 5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10^10 vp on Days 1 and 57.
OG003
Group 4: Ad26.COV2.S 3.5x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10^10 vp on Days 1 and 57.
OG004
Group 5: Ad26.COV2.S 2.5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10^10 vp on Days 1 and 57.
OG005
Group 6: Ad26.COV2.S 1.25x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10^10 vp on Days 1 and 57.
Units
Counts
Participants
OG000249
OG001191
OG002250
OG003
Title
Denominators
Categories
Title
Measurements
OG0002351(1849 to 2989)
OG0011714(1305 to 2250)
OG0022189(1726 to 2775)
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
OG002
Group 1 (1 dose) vs Group 3 (1 dose)
Geometric mean ratio
1.15
2-Sided
97.5
0.926
1.440
Non-Inferiority
Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.
OG002
OG004
Primary
Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 14 Days After Second Vaccination
Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
The per protocol immunogenicity set included all randomized and vaccinated participants for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
ELISA Units per millilitre (EU/mL)
14 days after second vaccination (at Day 71)
ID
Title
Description
OG000
Group 1: Ad26.COV2.S 9x10^10 vp
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10^10 viral particles (vp) on Days 1 and 57.
OG001
Group 2: Ad26.COV2.S 7x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 7x10^10 vp on Days 1 and 57.
OG002
Group 3: Ad26.COV2.S 5x10^10 vp
Secondary
Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA
Percentage of participants with serological response to vaccination to SARS-COV-2 S protein as measured by ELISA were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) the baseline (pre-dose 1) sample value was less than or equal to (<=) lower limit of quantification (LLOQ) and the post-baseline sample was greater than (>) LLOQ; (2) the baseline sample (pre-dose 1) value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>=4-fold) increase from the baseline sample value. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
The per protocol immunogenicity set included all randomized and vaccinated participants for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Posted
Number
Percentage of participants
Day 29, Day 57, Day 71, Week 32, and Week 60
ID
Title
Description
OG000
Group 1: Ad26.COV2.S 9x10^10 vp
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10^10 viral particles (vp) on Days 1 and 57.
OG001
Group 2: Ad26.COV2.S 7x10^10 vp
Secondary
Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA
Geometric mean concentration of SARS-CoV-2 S protein binding antibody measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
The per protocol immunogenicity set included all randomized and vaccinated participants for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
ELISA Unit (EU)/mL
Day 29, Day 57, Day 71, Week 32, and Week 60
ID
Title
Description
OG000
Group 1: Ad26.COV2.S 9x10^10 vp
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10^10 viral particles (vp) on Days 1 and 57.
OG001
Group 2: Ad26.COV2.S 7x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 7x10^10 vp on Days 1 and 57.
OG002
Group 3: Ad26.COV2.S 5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10^10 vp on Days 1 and 57.
Secondary
Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination
An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participant in their e-diary for 7 days after each vaccination. Solicited local AEs included injection site pain/tenderness, erythema and swelling at the study vaccine injection site. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Full analysis set included all participants with at least one vaccine administration documented. Here, 'n' (number of participants analyzed) signifies number of participants evaluable for this timepoint.
Posted
Count of Participants
Participants
7 days after each vaccination (first vaccination [at Day 8], second vaccination [at Day 64])
ID
Title
Description
OG000
Group 1: Ad26.COV2.S 9x10^10 vp
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10^10 viral particles (vp) on Days 1 and 57.
OG001
Group 2: Ad26.COV2.S 7x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 7x10^10 vp on Days 1 and 57.
Secondary
Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination
An AE was any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) were noted in the subject diary after 7 days of each vaccination. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Full analysis set included all participants with at least one vaccine administration documented. Here, 'n' (number of subjects analysed) signifies number of subjects evaluable for this timepoint.
Posted
Count of Participants
Participants
7 days after each vaccination (first vaccination [at Day 8], second vaccination [at Day 64])
ID
Title
Description
OG000
Group 1: Ad26.COV2.S 9x10^10 vp
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10^10 viral particles (vp) on Days 1 and 57.
OG001
Group 2: Ad26.COV2.S 7x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 7x10^10 vp on Days 1 and 57.
OG002
Group 3: Ad26.COV2.S 5x10^10 vp
Secondary
Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination
Unsolicited AEs were all AEs for which the subject was not specifically questioned in the subject diary. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Full analysis set included all participants with at least one vaccine administration documented. Here, 'n' (number of participants analyzed) signifies number of participants evaluable for this timepoint.
Posted
Count of Participants
Participants
28 days after each vaccination (first vaccination [at Day 29], second vaccination [at Day 85])
ID
Title
Description
OG000
Group 1: Ad26.COV2.S 9x10^10 vp
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10^10 viral particles (vp) on Days 1 and 57.
OG001
Group 2: Ad26.COV2.S 7x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 7x10^10 vp on Days 1 and 57.
OG002
Group 3: Ad26.COV2.S 5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10^10 vp on Days 1 and 57.
Secondary
Number of Participants With Serious Adverse Events (SAEs)
SAE was any untoward medical occurrence that at any dose may results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Full analysis set included all participants with at least one vaccine administration documented.
Posted
Count of Participants
Participants
From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
ID
Title
Description
OG000
Group 1: Ad26.COV2.S 9x10^10 vp
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10^10 viral particles (vp) on Days 1 and 57.
OG001
Group 2: Ad26.COV2.S 7x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 7x10^10 vp on Days 1 and 57.
OG002
Group 3: Ad26.COV2.S 5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10^10 vp on Days 1 and 57.
Secondary
Number of Participants With Adverse Events of Special Interest (AESIs)
AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with thrombocytopenia syndrome were considered to be an AESI. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Full analysis set included all participants with at least one vaccine administration documented.
Posted
Count of Participants
Participants
From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
ID
Title
Description
OG000
Group 1: Ad26.COV2.S 9x10^10 vp
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10^10 viral particles (vp) on Days 1 and 57.
OG001
Group 2: Ad26.COV2.S 7x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 7x10^10 vp on Days 1 and 57.
OG002
Group 3: Ad26.COV2.S 5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10^10 vp on Days 1 and 57.
Secondary
Number of Participants With AEs Leading to Study Discontinuation
Number of participants with AEs leading to study discontinuation were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Full analysis set included all participants with at least one vaccine administration documented.
Posted
Count of Participants
Participants
Up to 60 weeks
ID
Title
Description
OG000
Group 1: Ad26.COV2.S 9x10^10 vp
Participants in the main study received Intramuscular (IM) injection of Ad26.COV2.S 9x10^10 viral particles (vp) on Days 1 and 57.
OG001
Group 2: Ad26.COV2.S 7x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 7x10^10 vp on Days 1 and 57.
OG002
Group 3: Ad26.COV2.S 5x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 5x10^10 vp on Days 1 and 57.
OG003
Group 4: Ad26.COV2.S 3.5x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10^10 vp on Days 1 and 57.
Secondary
Number of Participants With Medically-Attended Adverse Events (MAAEs)
MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Full analysis set included all participants with at least one vaccine administration documented.
Posted
Count of Participants
Participants
6 months after second vaccination (up to 32 weeks)
ID
Title
Description
OG000
Group 1: Ad26.COV2.S 9x10^10 vp
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10^10 viral particles (vp) on Days 1 and 57.
OG001
Group 2: Ad26.COV2.S 7x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 7x10^10 vp on Days 1 and 57.
OG002
Group 3: Ad26.COV2.S 5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10^10 vp on Days 1 and 57.
Time Frame
From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Description
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
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
Group 1: Ad26.COV2.S 9x10^10 vp
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10^10 viral particles (vp) on Days 1 and 57.
1
288
13
288
245
288
EG001
Group 2: Ad26.COV2.S 7x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 7x10^10 vp on Days 1 and 57.
0
221
3
221
187
221
EG002
Group 3: Ad26.COV2.S 5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10^10 vp on Days 1 and 57.
0
291
4
291
236
291
EG003
Group 4: Ad26.COV2.S 3.5x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10^10 vp on Days 1 and 57.
0
220
4
220
188
220
EG004
Group 5: Ad26.COV2.S 2.5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10^10 vp on Days 1 and 57.
0
288
3
288
228
288
EG005
Group 6: Ad26.COV2.S 1.25x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10^10 vp on Days 1 and 57.
1
285
5
285
217
285
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Non-systematic Assessment
EG0000 events0 affected288 at risk
EG0010 events0 affected221 at risk
EG0021 events1 affected291 at risk
EG0030 events0 affected220 at risk
EG0040 events0 affected288 at risk
EG0050 events0 affected285 at risk
Myopericarditis
Cardiac disorders
MedDRA 26.0
Non-systematic Assessment
EG0002 events1 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA 26.0
Non-systematic Assessment
EG0000 events0 affected288 at risk
EG0010 events0 affected221 at risk
EG0022 events1 affected291 at risk
EG003
Anal Fistula
Gastrointestinal disorders
MedDRA 26.0
Non-systematic Assessment
EG0000 events0 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Death
General disorders
MedDRA 26.0
Non-systematic Assessment
EG0000 events0 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Drowning
General disorders
MedDRA 26.0
Non-systematic Assessment
EG0001 events1 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 26.0
Non-systematic Assessment
EG0000 events0 affected288 at risk
EG0010 events0 affected221 at risk
EG0021 events1 affected291 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 26.0
Non-systematic Assessment
EG0002 events1 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 26.0
Non-systematic Assessment
EG0001 events1 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Pelvic Abscess
Infections and infestations
MedDRA 26.0
Non-systematic Assessment
EG0001 events1 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 26.0
Non-systematic Assessment
EG0000 events0 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Pyelonephritis Acute
Infections and infestations
MedDRA 26.0
Non-systematic Assessment
EG0000 events0 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Ankle Fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Non-systematic Assessment
EG0000 events0 affected288 at risk
EG0011 events1 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Gun Shot Wound
Injury, poisoning and procedural complications
MedDRA 26.0
Non-systematic Assessment
EG0001 events1 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Stab Wound
Injury, poisoning and procedural complications
MedDRA 26.0
Non-systematic Assessment
EG0001 events1 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Intervertebral Disc Protrusion
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Non-systematic Assessment
EG0000 events0 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Tongue Neoplasm Malignant Stage Unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Non-systematic Assessment
EG0002 events1 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Carotid Artery Dissection
Nervous system disorders
MedDRA 26.0
Non-systematic Assessment
EG0000 events0 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Myasthenia Gravis
Nervous system disorders
MedDRA 26.0
Non-systematic Assessment
EG0001 events1 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 26.0
Non-systematic Assessment
EG0000 events0 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Syncope
Nervous system disorders
MedDRA 26.0
Non-systematic Assessment
EG0000 events0 affected288 at risk
EG0010 events0 affected221 at risk
EG0021 events1 affected291 at risk
EG003
Abortion Spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 26.0
Non-systematic Assessment
EG0002 events1 affected288 at risk
EG0010 events0 affected221 at risk
EG0021 events1 affected291 at risk
EG003
Gestational Diabetes
Pregnancy, puerperium and perinatal conditions
MedDRA 26.0
Non-systematic Assessment
EG0000 events0 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 26.0
Non-systematic Assessment
EG0002 events1 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Anxiety Disorder
Psychiatric disorders
MedDRA 26.0
Non-systematic Assessment
EG0000 events0 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Depression
Psychiatric disorders
MedDRA 26.0
Non-systematic Assessment
EG0000 events0 affected288 at risk
EG0011 events1 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Psychotic Disorder
Psychiatric disorders
MedDRA 26.0
Non-systematic Assessment
EG0002 events1 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Suicide Attempt
Psychiatric disorders
MedDRA 26.0
Non-systematic Assessment
EG0000 events0 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 26.0
Non-systematic Assessment
EG0000 events0 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Hydrosalpinx
Reproductive system and breast disorders
MedDRA 26.0
Non-systematic Assessment
EG0001 events1 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Ovarian Cyst Torsion
Reproductive system and breast disorders
MedDRA 26.0
Non-systematic Assessment
EG0000 events0 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Ovarian Disorder
Reproductive system and breast disorders
MedDRA 26.0
Non-systematic Assessment
EG0000 events0 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Vaginal Haemorrhage
Reproductive system and breast disorders
MedDRA 26.0
Non-systematic Assessment
EG0000 events0 affected288 at risk
EG0011 events1 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Non-systematic Assessment
EG0000 events0 affected288 at risk
EG0010 events0 affected221 at risk
EG0020 events0 affected291 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Non-systematic Assessment
EG0005 events5 affected288 at risk
EG0011 events1 affected221 at risk
EG0029 events8 affected291 at risk
EG0030 events0 affected220 at risk
EG0047 events6 affected288 at risk
EG0050 events0 affected285 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26.0
Non-systematic Assessment
EG0008 events8 affected288 at risk
EG0016 events5 affected221 at risk
EG0021 events1 affected291 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.0
Non-systematic Assessment
EG0006 events6 affected288 at risk
EG0013 events3 affected221 at risk
EG0024 events3 affected291 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.0
Non-systematic Assessment
EG0007 events6 affected288 at risk
EG0016 events5 affected221 at risk
EG0022 events2 affected291 at risk
EG003
Nausea(Solicited)
Gastrointestinal disorders
MedDRA 26.0
Non-systematic Assessment
EG000123 events95 affected288 at risk
EG00199 events78 affected221 at risk
EG00279 events67 affected291 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 26.0
Non-systematic Assessment
EG0003 events3 affected288 at risk
EG0017 events5 affected221 at risk
EG0023 events3 affected291 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.0
Non-systematic Assessment
EG0004 events4 affected288 at risk
EG0011 events1 affected221 at risk
EG0026 events6 affected291 at risk
EG003
Chills
General disorders
MedDRA 26.0
Non-systematic Assessment
EG00013 events11 affected288 at risk
EG0015 events5 affected221 at risk
EG0022 events2 affected291 at risk
EG003
Fatigue
General disorders
MedDRA 26.0
Non-systematic Assessment
EG00019 events15 affected288 at risk
EG00114 events11 affected221 at risk
EG0029 events7 affected291 at risk
EG003
Fatigue(Solicited)
General disorders
MedDRA 26.0
Non-systematic Assessment
EG000248 events171 affected288 at risk
EG001202 events140 affected221 at risk
EG002207 events144 affected291 at risk
EG003
Pyrexia
General disorders
MedDRA 26.0
Non-systematic Assessment
EG00014 events9 affected288 at risk
EG00114 events10 affected221 at risk
EG0027 events5 affected291 at risk
EG003
Pyrexia(Solicited)
General disorders
MedDRA 26.0
Non-systematic Assessment
EG00077 events68 affected288 at risk
EG00142 events41 affected221 at risk
EG00237 events33 affected291 at risk
EG003
Vaccination Site Erythema(Solicited)
General disorders
MedDRA 26.0
Non-systematic Assessment
EG0003 events3 affected288 at risk
EG0015 events5 affected221 at risk
EG0029 events9 affected291 at risk
EG003
Vaccination Site Pain
General disorders
MedDRA 26.0
Non-systematic Assessment
EG0008 events7 affected288 at risk
EG00112 events8 affected221 at risk
EG0026 events4 affected291 at risk
EG003
Vaccination Site Pain(Solicited)
General disorders
MedDRA 26.0
Non-systematic Assessment
EG000306 events198 affected288 at risk
EG001242 events156 affected221 at risk
EG002284 events190 affected291 at risk
EG003
Vaccination Site Swelling(Solicited)
General disorders
MedDRA 26.0
Non-systematic Assessment
EG0008 events8 affected288 at risk
EG0019 events9 affected221 at risk
EG00212 events9 affected291 at risk
EG003
Covid-19
Infections and infestations
MedDRA 26.0
Non-systematic Assessment
EG00014 events9 affected288 at risk
EG00130 events21 affected221 at risk
EG00228 events20 affected291 at risk
EG003
Influenza
Infections and infestations
MedDRA 26.0
Non-systematic Assessment
EG00057 events35 affected288 at risk
EG00131 events26 affected221 at risk
EG00250 events38 affected291 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 26.0
Non-systematic Assessment
EG0003 events3 affected288 at risk
EG0017 events7 affected221 at risk
EG0028 events7 affected291 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 26.0
Non-systematic Assessment
EG0009 events8 affected288 at risk
EG0018 events6 affected221 at risk
EG0022 events1 affected291 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Non-systematic Assessment
EG00012 events10 affected288 at risk
EG00117 events12 affected221 at risk
EG0028 events6 affected291 at risk
EG003
Myalgia(Solicited)
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Non-systematic Assessment
EG000260 events183 affected288 at risk
EG001175 events126 affected221 at risk
EG002188 events144 affected291 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.0
Non-systematic Assessment
EG00028 events26 affected288 at risk
EG00120 events14 affected221 at risk
EG00212 events11 affected291 at risk
EG003
Headache(Solicited)
Nervous system disorders
MedDRA 26.0
Non-systematic Assessment
EG000260 events184 affected288 at risk
EG001202 events139 affected221 at risk
EG002195 events146 affected291 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Non-systematic Assessment
EG0009 events7 affected288 at risk
EG0017 events5 affected221 at risk
EG0024 events3 affected291 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Non-systematic Assessment
EG0006 events6 affected288 at risk
EG0010 events0 affected221 at risk
EG0023 events2 affected291 at risk
EG003
Hypertension
Vascular disorders
MedDRA 26.0
Non-systematic Assessment
EG0009 events6 affected288 at risk
EG0010 events0 affected221 at risk
EG0023 events3 affected291 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.
Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.
OG001
OG002
Group 2 (1 dose) vs Group 3 (1 dose)
Geometric mean ratio
1.07
2-Sided
97.5
0.844
1.356
Non-Inferiority
Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.
OG002
OG003
Group 4 (1 dose) vs Group 3 (1 dose)
Geometric mean ratio
0.94
2-Sided
97.5
0.742
1.193
Non-Inferiority
Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.
OG002
OG005
Group 6 (1 dose) vs Group 3 (1 dose)
Geometric mean ratio
0.81
2-Sided
97.5
0.648
1.007
Non-Inferiority
Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10^10 vp on Days 1 and 57.
OG003
Group 4: Ad26.COV2.S 3.5x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10^10 vp on Days 1 and Day 57.
OG004
Group 5: Ad26.COV2.S 2.5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10^10 vp on Days 1 and 57.
OG005
Group 6: Ad26.COV2.S 1.25x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10^10 vp on Days 1 and 57.
Units
Counts
Participants
OG000171
OG001130
OG002180
OG003134
OG004172
OG005184
Title
Denominators
Categories
Title
Measurements
OG0004997(4145 to 6023)
OG0013757(3030 to 4659)
OG0023855(3185 to 4666)
OG0033460(2781 to 4304)
OG0043641(2969 to 4465)
OG0053905(3113 to 4897)
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
OG002
Group 1 (2 doses) vs Group 3 (1 dose)
Geometric mean ratio
2.53
2-Sided
97.5
1.992
3.207
Non-Inferiority
Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.
OG000
OG002
Group 1 (2 doses) vs Group 3 (2 doses)
Geometric mean ratio
1.41
2-Sided
97.5
1.088
1.815
Non-Inferiority
Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.
OG002
OG004
Group 5 (2 doses) vs Group 3 (1 dose)
Geometric mean ratio
1.79
2-Sided
97.5
1.408
2.265
Non-Inferiority
Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.
OG002
OG004
Group 5 (2 doses) vs Group 3 (2 doses)
Geometric mean ratio
0.99
2-Sided
97.5
0.769
1.282
Non-Inferiority
Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.
OG001
OG002
Group 2 (2 doses) vs Group 3 (1 dose)
Geometric mean ratio
2.37
2-Sided
97.5
1.829
3.007
Non-Inferiority
Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.
OG001
OG002
Group 2 (2 doses) vs Group 3 (2 doses)
Geometric mean ratio
1.32
2-Sided
97.5
1.000
1.739
Non-Inferiority
Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.
OG002
OG003
Group 4 (2 doses) vs Group 3 (1 dose)
Geometric mean ratio
2.20
2-Sided
97.5
1.697
2.841
Non-Inferiority
Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.
OG002
OG003
Group 4 (2 doses) vs Group 3 (2 doses)
Geometric mean ratio
1.22
2-Sided
97.5
0.928
1.606
Non-Inferiority
Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.
OG002
OG005
Group 6 (2 doses) vs Group 3 (1 dose)
Geometric mean ratio
1.70
2-Sided
97.5
1.348
2.148
Non-Inferiority
Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.
OG002
OG005
Group 6 (2 doses) vs Group 3 (2 doses)
Geometric mean ratio
0.95
2-Sided
97.5
0.736
1.217
Non-Inferiority
Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.
Participants in the main study received IM injection of Ad26.COV2.S 7x10^10 vp on Days 1 and 57.
OG002
Group 3: Ad26.COV2.S 5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10^10 vp on Days 1 and 57.
OG003
Group 4: Ad26.COV2.S 3.5x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10^10 vp on Days 1 and 57.
OG004
Group 5: Ad26.COV2.S 2.5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10^10 vp on Days 1 and 57.
OG005
Group 6: Ad26.COV2.S 1.25x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10^10 vp on Days 1 and 57.
Units
Counts
Participants
OG000249
OG001191
OG002250
OG003189
OG004243
OG005251
Title
Denominators
Categories
Day 29
ParticipantsOG000249
ParticipantsOG001191
ParticipantsOG002250
ParticipantsOG003189
ParticipantsOG004243
ParticipantsOG005251
Title
Measurements
OG00082.7
OG00190.1
OG00278.8
OG003
Day 57
ParticipantsOG000216
ParticipantsOG001167
ParticipantsOG002217
ParticipantsOG003162
Day 71
ParticipantsOG000171
ParticipantsOG001130
ParticipantsOG002180
ParticipantsOG003134
Week 32
ParticipantsOG000112
ParticipantsOG00186
ParticipantsOG002128
ParticipantsOG00390
Week 60
ParticipantsOG00045
ParticipantsOG00133
ParticipantsOG00242
ParticipantsOG00337
OG003
Group 4: Ad26.COV2.S 3.5x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10^10 vp on Days 1 and 57.
OG004
Group 5: Ad26.COV2.S 2.5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10^10 vp on Days 1 and 57.
OG005
Group 6: Ad26.COV2.S 1.25x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10^10 vp on Days 1 and 57.
Units
Counts
Participants
OG000249
OG001191
OG002250
OG003189
OG004243
OG005251
Title
Denominators
Categories
Day 29
ParticipantsOG000249
ParticipantsOG001191
ParticipantsOG002250
ParticipantsOG003189
ParticipantsOG004243
ParticipantsOG005251
Title
Measurements
OG0002351(1849 to 2989)
OG0011714(1305 to 2250)
OG0022189(1726 to 2775)
OG003
Day 57
ParticipantsOG000216
ParticipantsOG001167
ParticipantsOG002217
ParticipantsOG003162
Day 71
ParticipantsOG000171
ParticipantsOG001130
ParticipantsOG002180
ParticipantsOG003134
Week 32
ParticipantsOG000112
ParticipantsOG00186
ParticipantsOG002128
ParticipantsOG00390
Week 60
ParticipantsOG00045
ParticipantsOG00133
ParticipantsOG00242
ParticipantsOG00337
OG002
Group 3: Ad26.COV2.S 5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10^10 vp on Days 1 and 57.
OG003
Group 4: Ad26.COV2.S 3.5x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10^10 vp on Days 1 and 57.
OG004
Group 5: Ad26.COV2.S 2.5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10^10 vp on Days 1 and 57.
OG005
Group 6: Ad26.COV2.S 1.25x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10^10 vp on Days 1 and 57.
Units
Counts
Participants
OG000288
OG001221
OG002291
OG003220
OG004288
OG005285
Title
Denominators
Categories
After first vaccination
ParticipantsOG000288
ParticipantsOG001221
ParticipantsOG002291
ParticipantsOG003220
ParticipantsOG004288
ParticipantsOG005285
Title
Measurements
OG000179
OG001143
OG002162
OG003
After second vaccination
ParticipantsOG000264
ParticipantsOG001200
ParticipantsOG002269
ParticipantsOG003199
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10^10 vp on Days 1 and 57.
OG003
Group 4: Ad26.COV2.S 3.5x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10^10 vp on Days 1 and 57.
OG004
Group 5: Ad26.COV2.S 2.5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10^10 vp on Days 1 and 57.
OG005
Group 6: Ad26.COV2.S 1.25x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10^10 vp on Days 1 and 57.
Units
Counts
Participants
OG000288
OG001221
OG002291
OG003220
OG004288
OG005285
Title
Denominators
Categories
After first vaccination
ParticipantsOG000288
ParticipantsOG001221
ParticipantsOG002291
ParticipantsOG003220
ParticipantsOG004288
ParticipantsOG005285
Title
Measurements
OG000204
OG001156
OG002173
OG003
After second vaccination
ParticipantsOG000264
ParticipantsOG001200
ParticipantsOG002269
ParticipantsOG003199
OG003
Group 4: Ad26.COV2.S 3.5x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10^10 vp on Days 1 and 57.
OG004
Group 5: Ad26.COV2.S 2.5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10^10 vp on Days 1 and 57.
OG005
Group 6: Ad26.COV2.S 1.25x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10^10 vp on Days 1 and 57.
Units
Counts
Participants
OG000288
OG001221
OG002291
OG003220
OG004288
OG005285
Title
Denominators
Categories
After first vaccination
ParticipantsOG000288
ParticipantsOG001221
ParticipantsOG002291
ParticipantsOG003220
ParticipantsOG004288
ParticipantsOG005285
Title
Measurements
OG00078
OG00160
OG00255
OG003
After second vaccination
ParticipantsOG000264
ParticipantsOG001200
ParticipantsOG002269
ParticipantsOG003199
OG003
Group 4: Ad26.COV2.S 3.5x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10^10 vp on Days 1 and 57.
OG004
Group 5: Ad26.COV2.S 2.5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10^10 vp on Days 1 and 57.
OG005
Group 6: Ad26.COV2.S 1.25x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10^10 vp on Days 1 and 57.
Units
Counts
Participants
OG000288
OG001221
OG002291
OG003220
OG004288
OG005285
Title
Denominators
Categories
Title
Measurements
OG00013
OG0013
OG0024
OG0034
OG0043
OG0055
OG003
Group 4: Ad26.COV2.S 3.5x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10^10 vp on Days 1 and 57.
OG004
Group 5: Ad26.COV2.S 2.5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10^10 vp on Days 1 and 57.
OG005
Group 6: Ad26.COV2.S 1.25x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10^10 vp on Days 1 and 57.
Units
Counts
Participants
OG000288
OG001221
OG002291
OG003220
OG004288
OG005285
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG004
Group 5: Ad26.COV2.S 2.5x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 2.5x10^10 vp on Days 1 and 57.
OG005
Group 6: Ad26.COV2.S 1.25x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 1.25x10^10 vp on Days 1 and 57.
Units
Counts
Participants
OG000288
OG001221
OG002291
OG003220
OG004288
OG005285
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG003
Group 4: Ad26.COV2.S 3.5x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10^10 vp on Days 1 and 57.
OG004
Group 5: Ad26.COV2.S 2.5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10^10 vp on Days 1 and 57.
OG005
Group 6: Ad26.COV2.S 1.25x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10^10 vp on Days 1 and 57.