A Study to Evaluate Efficacy, Safety, and Immunogenicity... | NCT04470427 | Trialant
NCT04470427
Sponsor
ModernaTX, Inc.
Status
Completed
Last Update Posted
Mar 21, 2024Actual
Enrollment
30,415Actual
Phase
Phase 3
Conditions
SARS-CoV-2
Interventions
mRNA-1273
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04470427
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
mRNA-1273-P301
Secondary IDs
ID
Type
Description
Link
75A50120C00034
Other Grant/Funding Number
BARDA
Brief Title
A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19
Official Title
A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older
Acronym
Not provided
Organization
ModernaTX, Inc.INDUSTRY
Status Module
Record Verification Date
Mar 2024
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
Jul 27, 2020Actual
Primary Completion Date
Dec 29, 2022Actual
Completion Date
Dec 29, 2022Actual
First Submitted Date
Jul 11, 2020
First Submission Date that Met QC Criteria
Jul 11, 2020
First Posted Date
Jul 14, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Dec 21, 2023
Results First Submitted that Met QC Criteria
Mar 19, 2024
Results First Posted Date
Mar 21, 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
Mar 19, 2024
Last Update Posted Date
Mar 21, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ModernaTX, Inc.INDUSTRY
Collaborators
Name
Class
Biomedical Advanced Research and Development Authority
FED
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
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
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2 years after the second dose of mRNA-1273.
Detailed Description
This is a 3-part Phase 3 study, with Part A (Blinded Phase), Part B (Open-label Observational Phase), and Part C (Booster Dose Phase). Participants in Part A are blinded to their treatment assignment, with participants receiving either mRNA-1273 vaccine or placebo. Part B of the study is designed to offer participants to be unblinded so that participants who received placebo in Part A can request 2 doses of open-label mRNA-1273 vaccine. Additionally, participants who choose to be unblinded and were only able to receive 1 dose of mRNA-1273 due to administrative reasons, can choose to receive the second dose of mRNA-1273 during Part B. In Part C, a booster dose will be provided for all eligible participants who choose to receive one.
Please access www.modernatx.com/cove-study for additional information, such as Study Overview, Participation, and Site Locations along with contact numbers for each location for the study.
Conditions Module
Conditions
SARS-CoV-2
Keywords
mRNA-1273
mRNA-1273 vaccine
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Virus Diseases
Messenger RNA
COVID-19
COVID-19 Vaccine
Moderna
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
30,415Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
mRNA-1273
Experimental
Part A (Blinded): Participants will receive 1 intramuscular (IM) injection of 100 microgram (μg) mRNA-1273 on Day 1 and on Day 29.
Part B (Open-label): Participants who receive mRNA-1273-matching placebo during Part A and choose to be unblinded by participating in Part B, will receive 1 IM injection of 100 μg mRNA-1273 on Day 1 and Day 29. Participants who are only able to receive 1 dose of mRNA-1273 due to administrative reasons, will receive 1 IM injection of 100 μg mRNA-1273 on Day 1, if the participant chooses.
Part C: Eligible participants in Part B who choose to receive booster dose of mRNA-1273, will receive 1 IM injection of 50 μg mRNA-1273 on Day 1.
Biological: mRNA-1273
Biological: Placebo
Placebo
Placebo Comparator
Part A only: Participants will receive 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29, if the participant chooses.
Biological: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
mRNA-1273
Biological
Sterile liquid for injection
mRNA-1273
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part A: Number of Participants With a First Occurrence of COVID-19 Starting 14 Days After Second Dose
COVID-19 cases were defined as participants meeting clinical criteria based both on symptoms for COVID-19 and on RT-PCR detection of SARS-CoV-2 from samples collected within 72 hours of the study participant reporting symptoms that met the definition of COVID-19.
An adjudication committee was assembled for the purpose of reviewing potential cases to determine if the criteria for COVID-19 were met.
From Day 43 (14 days after second dose) up to approximately 7 months after the second dose
Part A: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) After First Dose
Solicited ARs (local and systemic) were collected in electronic diary (eDiary) within 7 days of dosing. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. Severity grading for solicited ARs is based on modified Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials. Severity was graded 0-4; a lower score indicated lower severity and a higher score indicated greater severity. The Investigator determined if solicited AR was also to be recorded as an AE. Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.
up to Day 7 (7 days after first dose)
Part A: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) After Second Dose
Solicited ARs (local and systemic) were collected in eDiary within 7 days of dosing. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. Severity grading for solicited ARs is based on modified Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials. Severity was graded 0-4; lower score indicated lower severity and a higher score indicated greater severity. The Investigator determined if solicited AR was also to be recorded as an AE. Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section
Secondary Outcomes
Measure
Description
Time Frame
Part A: Number of Participants With Unsolicited AEs up to 28 Days After Any Injection Dose
Unsolicited AE was any AE reported by the participant that was not specified as an AR or was specified as a solicited AR in the protocol but started outside the protocol-defined, post-injection period for reporting solicited ARs. Unsolicited AEs were collected for the 28 days after any injection.
An AE was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A summary of all SAEs and all nonserious AEs ("Other") reported up to the end of the study, regardless of causality, is located in the Reported "Adverse Events" section.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
(Part A only) Participants who are at high risk of SARS-CoV-2 infection, defined as adults whose locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and COVID-19.
Understands and agrees to comply with the study procedures and provides written informed consent.
Able to comply with study procedures based on the assessment of the Investigator.
Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥12 consecutive months prior to Screening without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the Investigator to confirm postmenopausal status.
Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:
Has a negative pregnancy test at Screening and on the day of the first dose (Day 1, open-label Day 1, and booster dose Day 1).
Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 1).
Has agreed to continue adequate contraception through 3 months following the last dose (Day 29, open-label Day 29, and booster dose Day 1).
Is not currently breastfeeding.
Healthy adults or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
(Part C Only) Is currently enrolled in Part B of the current study (mRNA-1273-P301).
(Part C Only) Has received at least 1 dose of mRNA-1273 in the current study (mRNA-1273-P301).
Exclusion Criteria:
Is acutely ill or febrile 72 hours prior to or at Screening or dosing (Part B and Part C). Fever is defined as a body temperature ≥38.0°Celsius/100.4°Fahrenheit. Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled/dosed at the discretion of the Investigator.
Is pregnant or breastfeeding.
(Part A Only) Known history of SARS-CoV-2 infection.
Prior (Part A) or concurrent (Part B and Part C) administration of non-study coronavirus (SARS-CoV, Middle East Respiratory Syndrome [MERS]-CoV) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19.
(Part A Only) Demonstrated inability to comply with the study procedures.
An immediate family member or household member of this study's personnel.
Known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients.
Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.
Has received or plans to receive a vaccine within 28 days prior to the first dose (Day 1) or plans to receive a non-study vaccine within 28 days prior to or after any dose of investigational product (IP) (except for seasonal influenza vaccine).
(Part A only) Has participated in an interventional clinical study within 28 days prior to the day of enrollment.
Immunosuppressive or immunodeficient state, including human immunodeficiency virus (HIV) infection, asplenia, and recurrent severe infections.
Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to IP dose administration (for corticosteroids ≥20 milligram (mg)/day of prednisone equivalent).
Has received systemic immunoglobulins or blood products within 3 months prior to the day of IP dose administration.
Has donated ≥450 milliliters (mL) of blood products within 28 days prior to IP dose administration.
Part A participants received mRNA-1273, or placebo. After completion of Part A, participants could have chosen to be unblinded so that participants who received placebo in Part A could request to receive open-label mRNA-1273 in Part B. Eligible participants who received at least one dose of mRNA-1273 in the study had the option to receive a booster dose of mRNA-1273 in Part C.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A (Blinded): Placebo
Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).
FG001
Part A (Blinded): mRNA-1273
Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).
Periods
Title
Milestones
Reasons Not Completed
Part A: Blinded
Type
Comment
Milestone Data
STARTED
Randomization Set (Part A): All participants who were randomized, regardless of the participant's treatment status in the study. Participants were analyzed according to the treatment group to which they were randomized.
Baseline Characteristics Module
Baseline Analysis Population Description
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
Apr 7, 2022
Dec 21, 2023
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
MeSH Terms
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
Quadruple
Masking Description
Part A is observer-blind. Part B is open-label; participants can request to be unblinded by scheduling a Participant Decision clinic visit. Part C offers participants the option to receive a booster dose for those participants who received at least one dose of mRNA-1273 in the study.
Day 29 to Day 35 (from second dose to 7 days after second dose)
Parts A and B: Number of Participants With Medically Attended AEs (MAAEs) and AEs Leading to Discontinuation
An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner (HCP). A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Day 1 (after dosing) through end of study (up to Day 759)
Parts A and B: Number of Participants With Serious AEs (SAEs)
An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Day 1 (after dosing) through end of study (up to Day 759)
Up to 28 days after any dose
Parts A and B: Number of Participants With a First Occurrence of Severe COVID-19 Starting 14 Days After Second Dose
COVID-19 cases were defined as participants meeting clinical criteria based on symptoms for COVID-19 and reverse transcriptase polymerase chain reaction (RT-PCR) detection of SARS-CoV-2 from samples collected within 72 hours of the participant reporting symptoms meeting the definition of COVID-19.
An adjudication committee reviewed potential cases to determine if the criteria for COVID-19 were met.
Clinical signs indicative of severe COVID-19 systemic illness included any of the following: respiratory rate ≥30 per minute, heart rate ≥125 beats per minute, oxygen saturation (SpO2) ≤93% on room air at sea level, or partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FIO2) <300 millimeter of mercury (mm Hg), or respiratory failure or acute respiratory distress syndrome (ARDS), evidence of shock, or significant acute renal, hepatic, or neurologic dysfunction, or admission to an intensive care unit or death.
From Day 43 (14 days after second dose) up to approximately 8 months for Part A and from PDV/unblinding (at 4 months) to up to 8 months for Part B
Part A: Number of Participants With a First Occurrence of Either COVID-19 or SARS-CoV-2 Infection Regardless of Symptomatology or Severity Starting 14 Days After Second Dose
COVID-19 cases were defined as participants meeting clinical criteria based both on symptoms for COVID-19 and on RT-PCR detection of SARS-CoV-2 from samples collected within 72 hours of the study participant reporting symptoms that met the definition of COVID-19.
An adjudication committee was assembled for the purpose of reviewing potential cases to determine if the criteria for COVID-19 were met.
SARS-CoV-2 infection was defined by seroconversion due to infection measured by binding antibody (bAb) levels against SARS-CoV-2 nucleocapsid or by positive RT-PCR at predefined timepoints. Seroconversion was defined by the participant's serostatus at baseline.
From Day 43 (14 days after second dose) up to approximately 7 months after the second dose
Part A: Number of Participants With a Secondary Case Definition of COVID-19 Starting 14 Days After Second Dose
Secondary case definition of COVID-19 was defined as the presence of at least 1 of the following systemic symptoms: fever (temperature
≥38ºC), or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle aches or body aches, headache, new loss of taste or smell, sore throat, nasal congestion or rhinorrhea, nausea or vomiting, or diarrhea and a positive nasopharyngeal swab, nasal swab, or saliva sample (or respiratory sample, if hospitalized) for SARS-CoV-2 by RT-PCR.
From Day 43 (14 days after second dose) up to approximately 7 months after the second dose
Parts A and B: Number of Participants Who Died Due to a Cause Directly Attributed to a Complication of COVID-19 Starting 14 Days After Second Dose
From Day 43 (14 days after second dose) up to approximately 8 months for Part A and from PDV/unblinding (at 4 months) to up to 8 months for Part B
Part A: Number of Participants With a First Occurrence of COVID-19 Starting 14 Days After First Dose
COVID-19 cases were defined as participants meeting clinical criteria based both on symptoms for COVID-19 and on RT-PCR detection of SARS-CoV-2 from samples collected within 72 hours of the study participant reporting symptoms that met the definition of COVID-19.
An adjudication committee was assembled for the purpose of reviewing potential cases to determine if the criteria for COVID-19 were met.
From 14 days after first dose up to approximately 8 months
Part A: Number of Participants With a First Occurrence of COVID-19 Starting 14 Days After Second Dose Regardless of Evidence of Prior SARS-CoV-2 Infection
COVID-19 cases were defined as participants meeting clinical criteria based both on symptoms for COVID-19 and on RT-PCR detection of SARS-CoV-2 from samples collected within 72 hours of the study participant reporting symptoms that met the definition of COVID-19.
An adjudication committee was assembled for the purpose of reviewing potential cases to determine if the criteria for COVID-19 were met.
From Day 43 (14 days after second dose) up to approximately 7 months after the second dose
Part A: Number of Participants With a First Occurrence of SARS-CoV-2 Infection in the Absence of Symptoms Defining COVID-19 Starting 14 Days After Second Dose
SARS-CoV-2 infection was defined by seroconversion due to infection measured by binding antibody (bAb) levels against SARS-CoV-2 nucleocapsid or by positive RT-PCR at predefined timepoints. Seroconversion was defined by the participant's serostatus at baseline.
From Day 43 (14 days after second dose) up to approximately 7 months after the second dose
Part A: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb)
GMT (50% inhibitory dose [ID50], 80% inhibitory dose [ID80]) of nAb against SARS-CoV-2 pseudotyped viruses as measured by pseudovirus nAb assay is reported.
95% CI was based on the t-distribution of log-transformed values for GM titer, then back transformed to original scale for presentation.
Baseline SARS-CoV-2 Status: Positive if there is immunologic or virologic evidence of prior COVID-19, defined as positive RT-PCR test or positive Elecsys result at Day 1. Negative is defined as negative RT-PCR test and negative Elecsys result at Day 1.
Day 1, Day 29, Day 57
Part A: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb
The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants.
95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation. GMFR for ID50 and ID80 neutralizing antibodies against SARS-CoV-2 S-protein, as measured by pseudovirus neutralizing antibody is presented. Baseline SARS-CoV-2 Status: Positive if there is immunologic or virologic evidence of prior COVID-19, defined as positive RT-PCR test or positive Elecsys result at Day 1. Negative is defined as negative RT-PCR test and negative Elecsys result at Day 1
Day 29, Day 57
Part A: Percentage of Participants With Seroresponse Against SARS-CoV-2
Seroresponse to pseudovirus neutralizing antibody ID50 titer at a participant level is defined as a change from below the LLOQ to equal or above the LLOQ, or at least a 3.3-fold rise if baseline is equal to or above the LLOQ. Seroresponse to pseudovirus neutralizing antibody ID80 titer at a participant level is defined as a change from below the LLOQ to equal or above the LLOQ, or at least a 2.3-fold rise if baseline is equal to or above the LLOQ.
Baseline SARS-CoV-2 Status: Positive if there is immunologic or virologic evidence of prior COVID-19, defined as positive RT-PCR test or positive Elecsys result at Day 1. Negative is defined as negative RT-PCR test and negative Elecsys result at Day 1.
Day 29, Day 57
Part C: GMT of SARS-CoV-2 Specific nAb Measured by Pseudovirus (VAC62)
95% CI is calculated based on the t-distribution of the log-transformed values for GM value, then back transformed to the original scale for presentation.
Pre-booster (Baseline), post-booster Day 29 and post-booster Day 181
Part C: Percentage of Participants With Seroresponse Against SARS-CoV-2 Measured by Pseudovirus (VAC62)
Pseudovirus neutralizing antibody (VAC62) from pre-booster is presented. Seroresponse at a participant level is defined as a change from below the LLOQ to >= 4 x LLOQ, or at least a 4-fold rise if pre-booster is equal to or above the LLOQ.
Post-booster Day 29 and post-booster Day 181
Part C: Geometric Mean Concentration (GMC) of SARS-CoV-2 Specific nAb After BD Compared to After Second Dose in Part A Measured by Pseudovirus (VAC62)
95% CI is calculated based on the t-distribution of the log-transformed values for GMC, then back transformed to the original scale for presentation.
Part C BD Day 29 and Part A Day 57
Part C: Percentage of Participants With Seroresponse Against SARS-CoV-2 After BD Compared to After Second Dose in Part A
Pseudovirus neutralizing antibody (VAC62) are presented. Seroresponse at a participant level is defined as a change from below the LLOQ to equal or above 4 x LLOQ, or at least a4-fold rise if baseline (Pre- Dose 1) is equal to or above the LLOQ.
Part C BD Day 29 and Part A Day 57
Birmingham
Alabama
35211
United States
Hope Research Institute
Chandler
Arizona
85224
United States
Synexus Clinical Research US, Inc. - Phoenix West
Glendale
Arizona
85306
United States
Hope Research Institute
Peoria
Arizona
85018
United States
Hope Research Institute
Phoenix
Arizona
85018
United States
Quality of Life Medical and Research Center
Tucson
Arizona
85712
United States
Baptist Health Center for Clinical Research
Little Rock
Arkansas
72205
United States
Advanced Clinical Research - Rancho Paseo
Banning
California
92220
United States
University of California San Diego
La Jolla
California
92093
United States
eStudySite - La Mesa
La Mesa
California
91942
United States
UCLA Vine Street Clinic CRS
Los Angeles
California
90038
United States
VA Greater Los Angeles Healthcare (veterans only)
Los Angeles
California
90073
United States
Paradigm Clinical Research Institute Inc
Redding
California
96001
United States
Benchmark Research - Sacramento
Sacramento
California
95864
United States
Medical Center For Clinical Research - M3 Wake Research
San Diego
California
92108
United States
University of Colorado Hospital
Aurora
Colorado
80045
United States
Lynn Institute of The Rockies
Colorado Springs
Colorado
80918
United States
George Washington University
Washington D.C.
District of Columbia
20037
United States
Accel Research Site
DeLand
Florida
32720
United States
Research Centers of America
Hollywood
Florida
33024
United States
Jacksonville Center for Clinical Research
Jacksonville
Florida
32216
United States
Synexus - Optimal Research - Melbourne
Melbourne
Florida
32934
United States
Suncoast Research Group
Miami
Florida
33135
United States
University of Miami
Miami
Florida
33136
United States
Synexus Clinical Research US, Inc. - Orlando
Orlando
Florida
32806
United States
Palm Beach Research Center
West Palm Beach
Florida
33409
United States
Grady Health System
Atlanta
Georgia
30303
United States
Children's Healthcare of Atlanta
Atlanta
Georgia
30322
United States
Hope Clinic of The Emory Vaccine Center
Decatur
Georgia
30030
United States
Meridian Clinical Research
Savannah
Georgia
31406
United States
Clinical Research Atlanta
Stockbridge
Georgia
30281
United States
Synexus Clinical Research US, Inc. - Chicago
Chicago
Illinois
60602
United States
UIC Project WISH CRS
Chicago
Illinois
60612
United States
University of Chicago-Hospital
Chicago
Illinois
60637
United States
Johnson County Clin-Trials
Lenexa
Kansas
66219
United States
Alliance for Multispecialty Research
Newton
Kansas
67114
United States
Alliance for Multispecialty Research- East Wichita
Wichita
Kansas
67207
United States
Meridian Clinical Research
Baton Rouge
Louisiana
70808
United States
Benchmark Research - Metairie
Metairie
Louisiana
70006
United States
University of Maryland School of Medicine
Baltimore
Maryland
21201
United States
Synexus - Optimal Research - Rockville
Rockville
Maryland
20850
United States
Meridian Clinical Research
Rockville
Maryland
20854
United States
Brigham and Women's Hospital
Boston
Massachusetts
02115
United States
Henry Ford Health System
Detroit
Michigan
48202
United States
MediSync Clinical Research Hattiesburg Clinic
Petal
Mississippi
39465
United States
Saint Louis University
St Louis
Missouri
63104
United States
Sundance Clinical Research
St Louis
Missouri
63141
United States
Meridian Clinical Research
Grand Island
Nebraska
68803
United States
Meridian Clinical Research
Norfolk
Nebraska
68701
United States
Meridian Clinical Research
Omaha
Nebraska
68134
United States
Clinical Research Center of Nevada
Las Vegas
Nevada
89104
United States
AB Clinical Trials
Las Vegas
Nevada
89119
United States
Hackensack University Medical Center
Hackensack
New Jersey
07601
United States
New Jersey Medical School
Newark
New Jersey
07103
United States
Meridian Clinical Research
Binghamton
New York
13901
United States
Weill Cornell Chelsea - (CRS)
New York
New York
10010
United States
Weill Cornell Medical College
New York
New York
10065
United States
University of North Carolina at Chapel Hill
Chapel Hill
North Carolina
27599
United States
Tryon Medical Partners
Charlotte
North Carolina
28210
United States
Carolina Institute for Clinical Research - M3 Wake Research
Fayetteville
North Carolina
28304
United States
M3 Wake Research, Inc - M3 Wake
Raleigh
North Carolina
27612
United States
Trial Management Associates
Wilmington
North Carolina
28403
United States
Wake Forest University Health Sciences
Winston-Salem
North Carolina
27157
United States
Synexus Clinical Research US, Inc. - Cincinnati
Cincinnati
Ohio
45236
United States
New Horizons Clinical Research
Cincinnati
Ohio
45242
United States
Cincinnati CRS
Cincinnati
Ohio
45267
United States
Rapid Medical Research Inc
Cleveland
Ohio
44122
United States
Lynn Health Science Institute
Oklahoma City
Oklahoma
73112
United States
Crisor
Medford
Oregon
97504
United States
University of Pennsylvania
Philadelphia
Pennsylvania
19104
United States
UPMC University Center
Pittsburgh
Pennsylvania
15213
United States
Keystone VitaLink Research
Anderson
South Carolina
29621
United States
Keystone VitaLink Research - Greenville
Greenville
South Carolina
29615
United States
Coastal Carolina Research Center
Mt. Pleasant
South Carolina
29464
United States
Keystone VitaLink Research - Spartanburg
Spartanburg
South Carolina
29303
United States
Meridian Clinical Research
Dakota Dunes
South Dakota
57049
United States
WR-ClinSearch
Chattanooga
Tennessee
37421
United States
Alliance for Multispecialty Research
Knoxville
Tennessee
39720
United States
Vanderbilt University Medical Center, Medical Arts Building
Nashville
Tennessee
37232
United States
Vanderbilt University Medical Center, Medical Center North
Nashville
Tennessee
37232
United States
Benchmark Research - Austin
Austin
Texas
78705
United States
Synexus - Optimal Research - Austin
Austin
Texas
78705
United States
Tekton Research
Austin
Texas
78745
United States
Advanced Clinical Research - Be Well MD
Cedar Park
Texas
78613
United States
Global Medical Research - M3 Wake Research
Dallas
Texas
75224
United States
Synexus Clinical Research US, Inc. - Dallas
Dallas
Texas
75234
United States
Benchmark Research - Fort Worth
Fort Worth
Texas
76135
United States
University of Texas Medical Branch at Galveston
Galveston
Texas
77555
United States
Baylor College of Medicine
Houston
Texas
77030
United States
DM Clinical Research - Texas Center For Drug Development
Houston
Texas
77081
United States
Laguna Clinical Research
Laredo
Texas
78041
United States
Centex Studies
McAllen
Texas
78504
United States
Benchmark Research - San Angelo
San Angelo
Texas
76904
United States
Clinical Trials of Texas, Inc
San Antonio
Texas
78229
United States
DM Clinical Research
Tomball
Texas
77375
United States
Synexus Clinical Research US, Inc. - Salt Lake City
Murray
Utah
84123
United States
Foothill Family Clinic - North
Salt Lake City
Utah
84109
United States
Foothill Family Clinic-South Clinic
Salt Lake City
Utah
84121
United States
Kaiser Permanente - Seattle
Seattle
Washington
98101
United States
Derived
Kenny A, van der Laan L, Gilbert P, Carone M. Inference on Controlled Effects for Assessing Immune Correlates of Protection Based on a Cox Model. Stat Med. 2025 Dec;44(28-30):e70347. doi: 10.1002/sim.70347.
Ashby E, Janes H, Follmann D, Gilbert PB, Zhou H, Wang X, Girard B, Priddy F, Kublin JG, Corey L, Neuzil KM, Baden LR, El Sahly HM, Zhang B; COVE study group. Validating and leveraging non-SARS-CoV-2 respiratory infection as a negative control outcome in a phase 3 COVID-19 vaccine trial with extended observational follow-up. Am J Epidemiol. 2026 Jan 8;195(1):168-177. doi: 10.1093/aje/kwaf176.
Follmann D, Wang X, Baden LR, El Sahly HM, Essink B, Gilbert P, Janes HE, Kelley CF, Berman MA, Frank I, Chu E, Deng W, Priddy F, Dixit A, Tomassini JE, Das R, Miller J, Zhou H. Who to Boost When: The Effect of Age and Dosing Interval on Delta and Omicron COVID-19 Incidence in the Open-label Phase of the COVE Trial. Open Forum Infect Dis. 2024 Nov 25;11(12):ofae689. doi: 10.1093/ofid/ofae689. eCollection 2024 Dec.
Zhang B, Fong Y, Fintzi J, Chu E, Janes HE, Kenny A, Carone M, Benkeser D, van der Laan LWP, Deng W, Zhou H, Wang X, Lu Y, Yu C, Borate B, Chen H, Reeder I, Carpp LN, Houchens CR, Martins K, Jayashankar L, Huynh C, Fichtenbaum CJ, Kalams S, Gay CL, Andrasik MP, Kublin JG, Corey L, Neuzil KM, Priddy F, Das R, Girard B, El Sahly HM, Baden LR, Jones T, Donis RO, Koup RA, Gilbert PB, Follmann D; United States Government (USG) COVID-19 Immune Assays Team; Moderna, Inc. Team; Coronavirus Vaccine Prevention Network (CoVPN)/Coronavirus Efficacy (COVE) Team; USG/CoVPN Biostatistics Team. Omicron COVID-19 immune correlates analysis of a third dose of mRNA-1273 in the COVE trial. Nat Commun. 2024 Sep 11;15(1):7954. doi: 10.1038/s41467-024-52348-9.
Baden LR, El Sahly HM, Essink B, Follmann D, Hachigian G, Strout C, Overcash JS, Doblecki-Lewis S, Whitaker JA, Anderson EJ, Neuzil K, Corey L, Priddy F, Tomassini JE, Brown M, Girard B, Stolman D, Urdaneta V, Wang X, Deng W, Zhou H, Dixit A, Das R, Miller JM; COVE Trial Consortium. Long-term safety and effectiveness of mRNA-1273 vaccine in adults: COVE trial open-label and booster phases. Nat Commun. 2024 Aug 29;15(1):7469. doi: 10.1038/s41467-024-50376-z.
Fraiman J, Erviti J, Jones M, Greenland S, Whelan P, Kaplan RM, Doshi P. Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults. Vaccine. 2022 Sep 22;40(40):5798-5805. doi: 10.1016/j.vaccine.2022.08.036. Epub 2022 Aug 31.
El Sahly HM, Baden LR, Essink B, Montefiori D, McDermont A, Rupp R, Lewis M, Swaminathan S, Griffin C, Fragoso V, Miller VE, Girard B, Paila YD, Deng W, Tomassini JE, Paris R, Schodel F, Das R, August A, Leav B, Miller JM, Zhou H, Pajon R; Coronavirus Efficacy (COVE) Study Group. Humoral Immunogenicity of the mRNA-1273 Vaccine in the Phase 3 Coronavirus Efficacy (COVE) Trial. J Infect Dis. 2022 Nov 11;226(10):1731-1742. doi: 10.1093/infdis/jiac188.
El Sahly HM, Baden LR, Essink B, Doblecki-Lewis S, Martin JM, Anderson EJ, Campbell TB, Clark J, Jackson LA, Fichtenbaum CJ, Zervos M, Rankin B, Eder F, Feldman G, Kennelly C, Han-Conrad L, Levin M, Neuzil KM, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Polakowski L, Mascola JR, Ledgerwood JE, Graham BS, August A, Clouting H, Deng W, Han S, Leav B, Manzo D, Pajon R, Schodel F, Tomassini JE, Zhou H, Miller J; COVE Study Group. Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase. N Engl J Med. 2021 Nov 4;385(19):1774-1785. doi: 10.1056/NEJMoa2113017. Epub 2021 Sep 22.
Gilbert PB, Montefiori DC, McDermott A, Fong Y, Benkeser D, Deng W, Zhou H, Houchens CR, Martins K, Jayashankar L, Castellino F, Flach B, Lin BC, O'Connell S, McDanal C, Eaton A, Sarzotti-Kelsoe M, Lu Y, Yu C, Borate B, van der Laan LWP, Hejazi N, Huynh C, Miller J, El Sahly HM, Baden LR, Baron M, De La Cruz L, Gay C, Kalams S, Kelley CF, Kutner M, Andrasik MP, Kublin JG, Corey L, Neuzil KM, Carpp LN, Pajon R, Follmann D, Donis RO, Koup RA. Immune Correlates Analysis of the mRNA-1273 COVID-19 Vaccine Efficacy Trial. medRxiv [Preprint]. 2021 Aug 15:2021.08.09.21261290. doi: 10.1101/2021.08.09.21261290.
Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Mascola J, Polakowski L, Ledgerwood J, Graham BS, Bennett H, Pajon R, Knightly C, Leav B, Deng W, Zhou H, Han S, Ivarsson M, Miller J, Zaks T; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384(5):403-416. doi: 10.1056/NEJMoa2035389. Epub 2020 Dec 30.
FG002
Part B (Open-label): Placebo
Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.
FG003
Part B (Open-label): Placebo/mRNA-1273
Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.
FG004
Part B (Open-label): mRNA-1273
Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
FG005
Part C: mRNA-1273 Booster
Participants received 50 μg mRNA-1273 booster.
FG00015206 subjects
FG00115209 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Received Any Study Injection
FG00015166 subjects
FG00115180 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Per-Protocol (PP) Set:
Participants who received any study injection, were severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) negative (defined as no immunologic or virologic evidence of prior COVID-19 at Day 1 before the first dose), and had no major protocol deviations, Participants were analyzed according to the treatment group to which they were randomized. Participants who did not receive the second dose within 21 or 42 days after the first injection date were excluded from the PP Set.
FG00014164 subjects
FG00114287 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Per-Protocol Random Subcohort for Immunogenicity (PPRSI)
All participants in the FAS who were sampled into the random subcohort and received both planned doses (received the treatment the participant was randomized to with Dose 2 received within 21 or 42 days after Dose 1, and no major protocol deviation that impacted critical or key data.
FG000272 subjects
FG0011185 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Solicited Safety Set
All randomized participants who received at least 1 dose and contributed any solicited AR data; (had at least 1 post-baseline solicited safety assessment. Participants were included in the treatment group corresponding to the study vaccination they actually received.
FG00015159 subjects
FG00115179 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Safety Set
All randomized participants who received at least 1 dose. Participants were included in the treatment group corresponding to dose they actually received. For a participant who was randomized to placebo but received any dose of mRNA-1273 at any injection, the participant was included in the mRNA-1273 group in the Safety Set.
FG00015162 subjects
FG00115184 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Full Analysis Set
All randomized participants who received at least 1 dose. Participants were analyzed according to the treatment group to which they were randomized.
FG00015166 subjects
FG00115180 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
Completed Part A (from first dose up to participant decision visit (PDV)/unblinding) and continued to Part B Open-label.
FG00014375 subjects
FG00114661 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG000831 subjects
FG001548 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Discontinued from Study in Part A
FG000831 subjects
FG001548 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Part B :Open-label
Type
Comment
Milestone Data
STARTED
Randomization Set from Part A and who received at least 1 dose. Participants were analyzed according to the treatment group to which they actually received.
FG0000 subjects
FG0010 subjects
FG0022513 subjects
FG00312649 subjects
FG00415184 subjects
FG0050 subjects
Safety Set
All randomized participants who received at least 1 dose in Part A and continued in Part B.
Participants were included in the treatment group corresponding to dose they actually received. For a participant who was randomized to placebo but received any dose of mRNA-1273 at any injection, the participant was included in the mRNA-1273 group in the Safety Set.
FG0000 subjects
FG0010 subjects
FG0022513 subjects
FG003
PP Set
Participants who were randomized in Part A, and were SARS-CoV-2 negative and had no major protocol deviations that impacted critical data.
FG0000 subjects
FG0010 subjects
FG0022104 subjects
FG003
Participants Who Had PDV/Unblinding) and Had the Option to Receive Booster Dose in Part C
FG0000 subjects
FG0010 subjects
FG0021725 subjects
FG00312649 subjects
COMPLETED
Completed Part B (from first dose up to PDV/unblinding) and had the option to receive booster dose in Part C.
FG0000 subjects
FG0010 subjects
FG002149 subjects
FG003
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0022364 subjects
FG0032185 subjects
FG004
Type
Comment
Reasons
Other than specified
FG0000 subjects
FG0010 subjects
FG002788 subjects
FG003
Part C: Booster
Type
Comment
Milestone Data
STARTED
Safety Set: Participants who continued from Part B and opted to receive a booster dose.in Part C.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00519609 subjectsSafety Set: Analysis by treatment received.
PP Set
Participants who were randomized in Part A, previously receiving 2 doses of mRNA-1273, then received mRNA-1273 booster in Part C, and were pre-booster SARS-CoV-2 negative and had no major protocol deviations that impacted critical data.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
PP Immunogenicity Subset (PPIS)
Participants who were in PPRSI in Part A, randomized and received 2 doses of mRNA-1273 in Part A, were SARS-CoV-2 negative at baseline, received booster in Part C, and had no major protocol deviations that impacted critical data.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
PPIS-Negative (Neg)
Participants who were in Part C PPIS and were pre-booster SARS-CoV-2 negative (as determined by non-positive RT-PCR test and negative serology anti-SARS-CoV-2 assay test on or before BD-Day 1).
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
COMPLETED
Participants are considered to have completed the study if they complete the final visit at Day 759 (Month 25), 24 months following their receipt of the original second dose of investigational product (IP) (where original refers to the IP received following randomization).
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Discontinued from Study in Part C
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All randomized participants who received at least 1 dose of treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants randomized to mRNA-1273-matching placebo and received any study injection in Part A.
BG001
mRNA-1273
Participants randomized to mRNA-1273 and received any study injection in Part A.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00015166
BG00115180
BG00230346
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
BG00051.3± 15.60
BG00151.4± 15.50
BG00251.4± 15.55
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0007109
BG0017263
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0003109
BG0013121
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Race
Title
Measurements
White
BG00012001
BG00112031
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
Part A: Number of Participants With a First Occurrence of COVID-19 Starting 14 Days After Second Dose
COVID-19 cases were defined as participants meeting clinical criteria based both on symptoms for COVID-19 and on RT-PCR detection of SARS-CoV-2 from samples collected within 72 hours of the study participant reporting symptoms that met the definition of COVID-19.
An adjudication committee was assembled for the purpose of reviewing potential cases to determine if the criteria for COVID-19 were met.
Part A PP Set. Number analyzed=participants evaluable at specified timepoint.
Posted
Count of Participants
Participants
From Day 43 (14 days after second dose) up to approximately 7 months after the second dose
ID
Title
Description
OG000
Part A (Blinded): Placebo
Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).
OG001
Part A (Blinded): mRNA-1273
Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).
Units
Counts
Participants
OG00014164
OG00114287
Title
Denominators
Categories
Title
Measurements
OG000744
OG00155
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
Vaccine efficacy was defined as the percent reduction in the hazard of the primary endpoint (mRNA-1273 vs. placebo).
Null hypothesis of Vaccine Efficacy ≤30%, 95% CI.
Vaccine Efficacy (VE)
VE (percent) is demonstrated if the lower limit of the 2-sided confidence interval for the VE is above 30%.
<.0001
VE
93.2
2-Sided
95
91.0
94.8
VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.
Other
Primary
Part A: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) After First Dose
Solicited ARs (local and systemic) were collected in electronic diary (eDiary) within 7 days of dosing. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. Severity grading for solicited ARs is based on modified Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials. Severity was graded 0-4; a lower score indicated lower severity and a higher score indicated greater severity. The Investigator determined if solicited AR was also to be recorded as an AE. Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.
Solicited Safety Set: All randomized participants who received at least 1 dose and contributed any solicited AR data; (had at least 1 post-baseline solicited safety assessment. Participants were included in the treatment group corresponding to the study vaccination they actually received. Number analyzed=participants evaluable at specified timepoint.
Posted
Count of Participants
Participants
up to Day 7 (7 days after first dose)
ID
Title
Description
OG000
Part A (Blinded): Placebo
Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).
Primary
Part A: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) After Second Dose
Solicited ARs (local and systemic) were collected in eDiary within 7 days of dosing. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. Severity grading for solicited ARs is based on modified Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials. Severity was graded 0-4; lower score indicated lower severity and a higher score indicated greater severity. The Investigator determined if solicited AR was also to be recorded as an AE. Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section
Solicited Safety Set: Randomized participants who received at least 1 dose and contributed any solicited AR data. Participants were included in the treatment group corresponding to the study vaccination they actually received. Number analyzed=participants evaluable at specified timepoint. No solicited ARs were collected in Part B because sufficient data had already been captured and analyzed in Part A.
Posted
Count of Participants
Participants
Day 29 to Day 35 (from second dose to 7 days after second dose)
ID
Title
Description
OG000
Part A (Blinded): Placebo
Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).
Primary
Parts A and B: Number of Participants With Medically Attended AEs (MAAEs) and AEs Leading to Discontinuation
An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner (HCP). A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Safety Set: All randomized participants who received at least 1 dose. Participants were included in the treatment group corresponding to dose they actually received. For a participant who was randomized to placebo but received any dose of mRNA-1273 at any injection, the participant was included in the mRNA-1273 group in the Safety Set.
Posted
Count of Participants
Participants
Day 1 (after dosing) through end of study (up to Day 759)
ID
Title
Description
OG000
Part A (Blinded): Placebo
Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).
OG001
Part A (Blinded): mRNA-1273
Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).
OG002
Part B (Open-label): Placebo
Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.
Primary
Parts A and B: Number of Participants With Serious AEs (SAEs)
An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Safety Set: All randomized participants who received at least 1 dose. Participants were included in the treatment group corresponding to dose they actually received. For a participant who was randomized to placebo but received any dose of mRNA-1273 at any injection, the participant was included in the mRNA-1273 group in the Safety Set.
Posted
Count of Participants
Participants
Day 1 (after dosing) through end of study (up to Day 759)
ID
Title
Description
OG000
Part A (Blinded): Placebo
Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).
OG001
Part A (Blinded): mRNA-1273
Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).
OG002
Part B (Open-label): Placebo
Secondary
Part A: Number of Participants With Unsolicited AEs up to 28 Days After Any Injection Dose
Unsolicited AE was any AE reported by the participant that was not specified as an AR or was specified as a solicited AR in the protocol but started outside the protocol-defined, post-injection period for reporting solicited ARs. Unsolicited AEs were collected for the 28 days after any injection.
An AE was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A summary of all SAEs and all nonserious AEs ("Other") reported up to the end of the study, regardless of causality, is located in the Reported "Adverse Events" section.
Safety Set: All randomized participants who received at least 1 dose. Participants were included in the treatment group corresponding to dose they actually received. For a participant who was randomized to placebo but received any dose of mRNA-1273 at any injection, the participant was included in the mRNA-1273 group in the Safety Set.
Posted
Count of Participants
Participants
Up to 28 days after any dose
ID
Title
Description
OG000
Part A (Blinded): Placebo
Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).
OG001
Part A (Blinded): mRNA-1273
Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).
Secondary
Parts A and B: Number of Participants With a First Occurrence of Severe COVID-19 Starting 14 Days After Second Dose
COVID-19 cases were defined as participants meeting clinical criteria based on symptoms for COVID-19 and reverse transcriptase polymerase chain reaction (RT-PCR) detection of SARS-CoV-2 from samples collected within 72 hours of the participant reporting symptoms meeting the definition of COVID-19.
An adjudication committee reviewed potential cases to determine if the criteria for COVID-19 were met.
Clinical signs indicative of severe COVID-19 systemic illness included any of the following: respiratory rate ≥30 per minute, heart rate ≥125 beats per minute, oxygen saturation (SpO2) ≤93% on room air at sea level, or partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FIO2) <300 millimeter of mercury (mm Hg), or respiratory failure or acute respiratory distress syndrome (ARDS), evidence of shock, or significant acute renal, hepatic, or neurologic dysfunction, or admission to an intensive care unit or death.
Parts A and B PP Sets. Number analyzed=participants evaluable at specified timepoint.
Posted
Count of Participants
Participants
From Day 43 (14 days after second dose) up to approximately 8 months for Part A and from PDV/unblinding (at 4 months) to up to 8 months for Part B
ID
Title
Description
OG000
Part A (Blinded): Placebo
Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).
OG001
Part A (Blinded): mRNA-1273
Secondary
Part A: Number of Participants With a First Occurrence of Either COVID-19 or SARS-CoV-2 Infection Regardless of Symptomatology or Severity Starting 14 Days After Second Dose
COVID-19 cases were defined as participants meeting clinical criteria based both on symptoms for COVID-19 and on RT-PCR detection of SARS-CoV-2 from samples collected within 72 hours of the study participant reporting symptoms that met the definition of COVID-19.
An adjudication committee was assembled for the purpose of reviewing potential cases to determine if the criteria for COVID-19 were met.
SARS-CoV-2 infection was defined by seroconversion due to infection measured by binding antibody (bAb) levels against SARS-CoV-2 nucleocapsid or by positive RT-PCR at predefined timepoints. Seroconversion was defined by the participant's serostatus at baseline.
Part A PP Set. Number analyzed=participants evaluable at specified timepoint.
Posted
Count of Participants
Participants
From Day 43 (14 days after second dose) up to approximately 7 months after the second dose
ID
Title
Description
OG000
Part A (Blinded): Placebo
Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).
OG001
Part A (Blinded): mRNA-1273
Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).
Secondary
Part A: Number of Participants With a Secondary Case Definition of COVID-19 Starting 14 Days After Second Dose
Secondary case definition of COVID-19 was defined as the presence of at least 1 of the following systemic symptoms: fever (temperature
≥38ºC), or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle aches or body aches, headache, new loss of taste or smell, sore throat, nasal congestion or rhinorrhea, nausea or vomiting, or diarrhea and a positive nasopharyngeal swab, nasal swab, or saliva sample (or respiratory sample, if hospitalized) for SARS-CoV-2 by RT-PCR.
Part A PP Set. Number analyzed=participants evaluable at specified timepoint.
Posted
Count of Participants
Participants
From Day 43 (14 days after second dose) up to approximately 7 months after the second dose
ID
Title
Description
OG000
Part A (Blinded): Placebo
Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).
OG001
Part A (Blinded): mRNA-1273
Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).
Units
Counts
Participants
Secondary
Parts A and B: Number of Participants Who Died Due to a Cause Directly Attributed to a Complication of COVID-19 Starting 14 Days After Second Dose
Parts A and B PP Set. Number analyzed=participants evaluable at specified timepoint.
Posted
Count of Participants
Participants
From Day 43 (14 days after second dose) up to approximately 8 months for Part A and from PDV/unblinding (at 4 months) to up to 8 months for Part B
ID
Title
Description
OG000
Part A (Blinded): Placebo
Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).
OG001
Part A (Blinded): mRNA-1273
Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).
OG002
Part B (Open-label): Placebo
Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.
OG003
Part B (Open-label): Placebo/mRNA-1273
Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.
Secondary
Part A: Number of Participants With a First Occurrence of COVID-19 Starting 14 Days After First Dose
COVID-19 cases were defined as participants meeting clinical criteria based both on symptoms for COVID-19 and on RT-PCR detection of SARS-CoV-2 from samples collected within 72 hours of the study participant reporting symptoms that met the definition of COVID-19.
An adjudication committee was assembled for the purpose of reviewing potential cases to determine if the criteria for COVID-19 were met.
Part A PP Set. Number analyzed=participants evaluable at specified timepoint.
Posted
Count of Participants
Participants
From 14 days after first dose up to approximately 8 months
ID
Title
Description
OG000
Part A (Blinded): Placebo
Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).
OG001
Part A (Blinded): mRNA-1273
Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).
Units
Counts
Participants
Secondary
Part A: Number of Participants With a First Occurrence of COVID-19 Starting 14 Days After Second Dose Regardless of Evidence of Prior SARS-CoV-2 Infection
COVID-19 cases were defined as participants meeting clinical criteria based both on symptoms for COVID-19 and on RT-PCR detection of SARS-CoV-2 from samples collected within 72 hours of the study participant reporting symptoms that met the definition of COVID-19.
An adjudication committee was assembled for the purpose of reviewing potential cases to determine if the criteria for COVID-19 were met.
Part A FAS. Number analyzed=participants evaluable at specified timepoint.
Posted
Count of Participants
Participants
From Day 43 (14 days after second dose) up to approximately 7 months after the second dose
ID
Title
Description
OG000
Part A (Blinded): Placebo
Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).
OG001
Part A (Blinded): mRNA-1273
Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).
Units
Counts
Participants
Secondary
Part A: Number of Participants With a First Occurrence of SARS-CoV-2 Infection in the Absence of Symptoms Defining COVID-19 Starting 14 Days After Second Dose
SARS-CoV-2 infection was defined by seroconversion due to infection measured by binding antibody (bAb) levels against SARS-CoV-2 nucleocapsid or by positive RT-PCR at predefined timepoints. Seroconversion was defined by the participant's serostatus at baseline.
Part A PP Set. Number analyzed=participants evaluable at specified timepoint.
Posted
Count of Participants
Participants
From Day 43 (14 days after second dose) up to approximately 7 months after the second dose
ID
Title
Description
OG000
Part A (Blinded): Placebo
Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).
OG001
Part A (Blinded): mRNA-1273
Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).
Units
Counts
Participants
Secondary
Part A: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb)
GMT (50% inhibitory dose [ID50], 80% inhibitory dose [ID80]) of nAb against SARS-CoV-2 pseudotyped viruses as measured by pseudovirus nAb assay is reported.
95% CI was based on the t-distribution of log-transformed values for GM titer, then back transformed to original scale for presentation.
Baseline SARS-CoV-2 Status: Positive if there is immunologic or virologic evidence of prior COVID-19, defined as positive RT-PCR test or positive Elecsys result at Day 1. Negative is defined as negative RT-PCR test and negative Elecsys result at Day 1.
Part A PPRSI Set. Number analyzed=participants evaluable at specified timepoint. Immunogenicity samples from the Part B were not tested and no data were generated as results were not thought to provide additional information.
Posted
Geometric Mean
95% Confidence Interval
Titer
Day 1, Day 29, Day 57
ID
Title
Description
OG000
Part A (Blinded): Placebo
Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).
OG001
Part A (Blinded): mRNA-1273
Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).
Secondary
Part A: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb
The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants.
95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation. GMFR for ID50 and ID80 neutralizing antibodies against SARS-CoV-2 S-protein, as measured by pseudovirus neutralizing antibody is presented. Baseline SARS-CoV-2 Status: Positive if there is immunologic or virologic evidence of prior COVID-19, defined as positive RT-PCR test or positive Elecsys result at Day 1. Negative is defined as negative RT-PCR test and negative Elecsys result at Day 1
Part A PPRSI Set. Number analyzed=participants evaluable at specified timepoint. Immunogenicity samples from the Part B were not tested and no data were generated as results were not thought to provide additional information.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Day 29, Day 57
ID
Title
Description
OG000
Part A (Blinded): Placebo
Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).
OG001
Part A (Blinded): mRNA-1273
Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).
Secondary
Part A: Percentage of Participants With Seroresponse Against SARS-CoV-2
Seroresponse to pseudovirus neutralizing antibody ID50 titer at a participant level is defined as a change from below the LLOQ to equal or above the LLOQ, or at least a 3.3-fold rise if baseline is equal to or above the LLOQ. Seroresponse to pseudovirus neutralizing antibody ID80 titer at a participant level is defined as a change from below the LLOQ to equal or above the LLOQ, or at least a 2.3-fold rise if baseline is equal to or above the LLOQ.
Baseline SARS-CoV-2 Status: Positive if there is immunologic or virologic evidence of prior COVID-19, defined as positive RT-PCR test or positive Elecsys result at Day 1. Negative is defined as negative RT-PCR test and negative Elecsys result at Day 1.
Part A PPRSI Set. Number analyzed=participants evaluable at specified timepoint. Immunogenicity samples from the Part B were not tested and no data were generated as results were not thought to provide additional information.
Posted
Number
95% Confidence Interval
percentage of participants
Day 29, Day 57
ID
Title
Description
OG000
Part A (Blinded): Placebo
Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).
OG001
Part A (Blinded): mRNA-1273
Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).
Secondary
Part C: GMT of SARS-CoV-2 Specific nAb Measured by Pseudovirus (VAC62)
95% CI is calculated based on the t-distribution of the log-transformed values for GM value, then back transformed to the original scale for presentation.
Part C PPIS Set. Number analyzed=participants evaluable at specified timepoint.
Posted
Geometric Mean
95% Confidence Interval
Titer
Pre-booster (Baseline), post-booster Day 29 and post-booster Day 181
ID
Title
Description
OG000
Part C (Booster): mRNA-1273 Booster
Participants received 50 μg mRNA-1273 booster.
Units
Counts
Participants
OG000
Secondary
Part C: Percentage of Participants With Seroresponse Against SARS-CoV-2 Measured by Pseudovirus (VAC62)
Pseudovirus neutralizing antibody (VAC62) from pre-booster is presented. Seroresponse at a participant level is defined as a change from below the LLOQ to >= 4 x LLOQ, or at least a 4-fold rise if pre-booster is equal to or above the LLOQ.
Part C PPIS Set. Number analyzed=participants evaluable at specified timepoint.
Posted
Number
95% Confidence Interval
percentage of participants
Post-booster Day 29 and post-booster Day 181
ID
Title
Description
OG000
Part C (Booster): mRNA-1273 Booster
Participants received 50 μg mRNA-1273 booster.
Units
Counts
Participants
OG000
Secondary
Part C: Geometric Mean Concentration (GMC) of SARS-CoV-2 Specific nAb After BD Compared to After Second Dose in Part A Measured by Pseudovirus (VAC62)
95% CI is calculated based on the t-distribution of the log-transformed values for GMC, then back transformed to the original scale for presentation.
Part C PPIS Set pre-booster SARS-CoV-2 negative. Number analyzed=participants evaluable at specified timepoint.
Posted
Geometric Mean
95% Confidence Interval
arbitrary units (AU)/milliliters (mL)
Part C BD Day 29 and Part A Day 57
ID
Title
Description
OG000
Part C (Booster): mRNA-1273 Booster
Participants received 50 μg mRNA-1273 booster.
OG001
Part A mRNA-1273
Participants received 100 μg mRNA-1273 on a 2-dose injection schedule.
Units
Counts
Participants
OG000
Secondary
Part C: Percentage of Participants With Seroresponse Against SARS-CoV-2 After BD Compared to After Second Dose in Part A
Pseudovirus neutralizing antibody (VAC62) are presented. Seroresponse at a participant level is defined as a change from below the LLOQ to equal or above 4 x LLOQ, or at least a4-fold rise if baseline (Pre- Dose 1) is equal to or above the LLOQ.
Part C PPIS Set pre-booster SARS-CoV-2 negative. Number analyzed=participants evaluable at specified timepoint.
Posted
Number
95% Confidence Interval
percentage of participants
Part C BD Day 29 and Part A Day 57
ID
Title
Description
OG000
Part C (Booster): mRNA-1273 Booster
Participants received 50 μg mRNA-1273 booster.
OG001
Part A mRNA-1273
Participants received 100 μg mRNA-1273 on a 2-dose injection schedule.
Units
Counts
Participants
OG000
Time Frame
up to Day 759 (end of study)
Description
All-cause Mortality: Randomized Set for Part A & Safety Sets for Parts B&C.SAEs/"other" AEs: Safety Sets for Parts A&B&C.
Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
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
Part A (Blinded): Placebo
Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).
18
15,206
308
15,162
2,783
15,162
EG001
Part A (Blinded): mRNA-1273
Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).
16
15,209
292
15,184
2,247
15,184
EG002
Part B (Open-label): Placebo
Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.
2
2,513
15
2,513
42
2,513
EG003
Part B (Open-label): Placebo/mRNA-1273
Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.
23
12,649
536
12,649
1,739
12,649
EG004
Part B (Open-label): mRNA-1273
Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
35
15,184
516
15,184
1,404
15,184
EG005
Part C: mRNA-1273 Booster
Participants received 50 μg mRNA-1273 booster.
52
19,609
755
19,609
8,277
19,609
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal abscess
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG0030 affected12,649 at risk
EG0042 affected15,184 at risk
EG0053 affected19,609 at risk
Abscess
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Abscess intestinal
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Abscess limb
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Acute sinusitis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Anal abscess
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Appendiceal abscess
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Appendicitis
Infections and infestations
Systematic Assessment
EG0005 affected15,162 at risk
EG0014 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Appendicitis perforated
Infections and infestations
Systematic Assessment
EG0001 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Arthritis bacterial
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Arthritis gonococcal
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Arthritis infective
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Bacteraemia
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Bacterial infection
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Bacterial sepsis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Biliary sepsis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Breast abscess
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Breast cellulitis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Bronchitis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0012 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
COVID-19
Infections and infestations
Systematic Assessment
EG00033 affected15,162 at risk
EG0011 affected15,184 at risk
EG0022 affected2,513 at risk
EG003
COVID-19 pneumonia
Infections and infestations
Systematic Assessment
EG00010 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Campylobacter sepsis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Cellulitis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0013 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Cellulitis staphylococcal
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Cholecystitis infective
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Clostridium bacteraemia
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Clostridium difficile colitis
Infections and infestations
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Clostridium difficile infection
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Coccidioidomycosis
Infections and infestations
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Colonic abscess
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Cystitis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Device related infection
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Diabetic foot infection
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Diverticulitis
Infections and infestations
Systematic Assessment
EG0004 affected15,162 at risk
EG0012 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Empyema
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Enterobacter sepsis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Enterococcal bacteraemia
Infections and infestations
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Epididymitis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Escherichia infection
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Extradural abscess
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Fournier's gangrene
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Gangrene
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Gastroenteritis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Gastroenteritis norovirus
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Gastroenteritis viral
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Gastrointestinal candidiasis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Gastrointestinal infection
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Giardiasis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Groin abscess
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Haematoma infection
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Helicobacter infection
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Hepatitis A
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Herpes simplex meningitis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Implant site infection
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Infected bite
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Infection
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Influenza
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Intervertebral discitis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Joint abscess
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Klebsiella sepsis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Liver abscess
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Localised infection
Infections and infestations
Systematic Assessment
EG0001 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Lung abscess
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Mastoiditis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Medical device site infection
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Meningitis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Meningitis aseptic
Infections and infestations
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Oesophageal candidiasis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Orchitis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Osteomyelitis
Infections and infestations
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Osteomyelitis acute
Infections and infestations
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Osteomyelitis bacterial
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Osteomyelitis chronic
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Otitis media acute
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Pericarditis infective
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0021 affected2,513 at risk
EG003
Perineal abscess
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Periorbital cellulitis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Perirectal abscess
Infections and infestations
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Peritoneal abscess
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Peritonitis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0012 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Peritonitis bacterial
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Pharyngitis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Pilonidal cyst
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Pneumonia
Infections and infestations
Systematic Assessment
EG00011 affected15,162 at risk
EG0019 affected15,184 at risk
EG0021 affected2,513 at risk
EG003
Pneumonia bacterial
Infections and infestations
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Pneumonia klebsiella
Infections and infestations
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Pneumonia mycoplasmal
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Pneumonia parainfluenzae viral
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Pneumonia pseudomonal
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Pneumonia respiratory syncytial viral
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Pneumonia staphylococcal
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Pneumonia streptococcal
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Post procedural cellulitis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Post procedural infection
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Postoperative abscess
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0012 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Postoperative wound infection
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Pyelonephritis
Infections and infestations
Systematic Assessment
EG0002 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Pyelonephritis acute
Infections and infestations
Systematic Assessment
EG0001 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Rhinovirus infection
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Salpingitis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Sepsis
Infections and infestations
Systematic Assessment
EG0004 affected15,162 at risk
EG0014 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Septic encephalopathy
Infections and infestations
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Septic shock
Infections and infestations
Systematic Assessment
EG0004 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Shigella infection
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Shigella sepsis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Sialoadenitis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Sinusitis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Spinal cord abscess
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Spinal cord infection
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Staphylococcal infection
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Staphylococcal sepsis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Streptococcal endocarditis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Streptococcal infection
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Streptococcal sepsis
Infections and infestations
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Subcutaneous abscess
Infections and infestations
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Suspected COVID-19
Infections and infestations
Systematic Assessment
EG0002 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Tonsillitis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Tooth abscess
Infections and infestations
Systematic Assessment
EG0002 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Toxic shock syndrome
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Urinary tract infection
Infections and infestations
Systematic Assessment
EG0005 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Urinary tract infection pseudomonal
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Urosepsis
Infections and infestations
Systematic Assessment
EG0001 affected15,162 at risk
EG0012 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Viral infection
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Viral pharyngitis
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Wound infection
Infections and infestations
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Acute myeloid leukaemia recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Adenocarcinoma gastric
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Adenocarcinoma pancreas
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Anal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Anaplastic large-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
B-cell small lymphocytic lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Benign lung neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Benign neoplasm of thymus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Benign pancreatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Benign salivary gland neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Bladder cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Bladder transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Bone cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Bone neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Borderline mucinous tumour of ovary
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0021 affected2,513 at risk
EG003
Breast cancer male
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Breast cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Breast cancer stage I
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Clear cell renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Colon adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Colon cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Colon cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Colon cancer stage III
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Colon cancer stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Colorectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Colorectal cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0021 affected2,513 at risk
EG003
Cutaneous T-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Diffuse large B-cell lymphoma stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Endometrial adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Endometrial cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0003 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Endometrial cancer stage I
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Ewing's sarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Gallbladder neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Gastric cancer stage III
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Gastrointestinal stromal tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Gastrointestinal tract adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Glioblastoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Glioblastoma multiforme
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Hepatocellular carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0012 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
High-grade B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Hodgkin's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Hormone receptor positive breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Intraductal proliferative breast lesion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0003 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Invasive breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0021 affected2,513 at risk
EG003
Invasive lobular breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Langerhans' cell histiocytosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Leiomyosarcoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Lentigo maligna
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Liposarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Lung adenocarcinoma stage I
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Lung adenocarcinoma stage III
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Lung carcinoma cell type unspecified stage I
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Lung carcinoma cell type unspecified stage III
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Lung carcinoma cell type unspecified stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Lung squamous cell carcinoma stage II
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Malignant ascites
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0012 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Malignant melanoma stage III
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Malignant neoplasm of thymus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Meningioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Metastases to liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Metastases to lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Metastases to lymph nodes
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Metastatic gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Metastatic malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Metastatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Metastatic renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Myxofibrosarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Neoplasm of orbit
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Neurilemmoma benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Neuroendocrine carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Neuroendocrine carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Neuroendocrine tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Non-Hodgkin's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Non-small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Non-small cell lung cancer stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Oesophageal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Osteochondroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Osteoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Ovarian cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Ovarian clear cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Pancreatic carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0021 affected2,513 at risk
EG003
Pancreatic carcinoma stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Pancreatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Papillary renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Papillary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Paranasal sinus neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Pelvic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Phaeochromocytoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Pituitary tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Plasma cell myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Pleomorphic malignant fibrous histiocytoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Prolactin-producing pituitary tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0004 affected15,162 at risk
EG0016 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Prostate cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Prostate cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Prostate cancer stage II
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Renal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Renal cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Salivary gland cancer stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Sarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Small cell lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Splenic marginal zone lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Squamous cell carcinoma of the tongue
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
T-cell type acute leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Throat cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Thymoma malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Thyroid cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0011 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Tongue neoplasm malignant stage unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Tonsil cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Urethral cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Uterine cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected15,162 at risk
EG0010 affected15,184 at risk
EG0020 affected2,513 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).
Units
Counts
Participants
OG00015151
OG00115166
Title
Denominators
Categories
Grade 1
Title
Measurements
OG0005134
OG0019329
Grade 2
Title
Measurements
OG0001782
OG0013134
Grade 3
Title
Measurements
OG000363
OG001849
Grade 4
Title
Measurements
OG0006
OG0015
OG001
Part A (Blinded): mRNA-1273
Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).
Units
Counts
Participants
OG00014578
OG00114691
Title
Denominators
Categories
Grade 1
Title
Measurements
OG0004346
OG0014847
Grade 2
Title
Measurements
OG0001558
OG0015800
Grade 3
Title
Measurements
OG000348
OG0012895
Grade 4
Title
Measurements
OG0003
OG00114
OG003
Part B (Open-label): Placebo/mRNA-1273
Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.
OG004
Part B (Open-label): mRNA-1273
Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Units
Counts
Participants
OG00015162
OG00115184
OG0022513
OG00312649
OG00415184
Title
Denominators
Categories
MAAEs
Title
Measurements
OG0004561
OG0013921
OG002109
OG0035513
OG0045809
AEs Leading to Discontinuation
Title
Measurements
OG00025
OG00127
OG0023
OG003
Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.
OG003
Part B (Open-label): Placebo/mRNA-1273
Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.
OG004
Part B (Open-label): mRNA-1273
Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Units
Counts
Participants
OG00015162
OG00115184
OG0022513
OG00312649
OG00415184
Title
Denominators
Categories
Title
Measurements
OG000308
OG001292
OG00215
OG003536
OG004516
Units
Counts
Participants
OG00015162
OG00115184
Title
Denominators
Categories
Title
Measurements
OG0004338
OG0014752
Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).
OG002
Part B (Open-label): Placebo
Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.
OG003
Part B (Open-label): Placebo/mRNA-1273
Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.
OG004
Part B (Open-label): mRNA-1273
Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Units
Counts
Participants
OG00014164
OG00114287
OG0022104
OG00312060
OG00414287
Title
Denominators
Categories
Title
Measurements
OG000106
OG0012
OG0021
OG0038
OG0041
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
VE
VE
98.2
2-Sided
95
92.8
99.6
VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.
Other
Units
Counts
Participants
OG00014164
OG00114287
Title
Denominators
Categories
Title
Measurements
OG0001339
OG001280
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
VE
82.0
2-Sided
95
79.5
84.2
VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model
Other
OG00014164
OG00114287
Title
Denominators
Categories
Title
Measurements
OG000807
OG00158
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
VE
93.4
2-Sided
95
91.4
94.9
VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.
Other
VE
OG004
Part B (Open-label): mRNA-1273
Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Units
Counts
Participants
OG00014164
OG00114287
OG0022104
OG00312060
OG00414287
Title
Denominators
Categories
Title
Measurements
OG0003
OG0010
OG0020
OG0030
OG0040
OG00014164
OG00114287
Title
Denominators
Categories
Title
Measurements
OG000769
OG00156
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
VE
93.3
2-Sided
95
91.1
94.9
VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.
Other
OG00015166
OG00115180
Title
Denominators
Categories
Title
Measurements
OG000754
OG00158
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
VE
82.0
2-Sided
95
79.5
84.3
VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.
Other
OG000
14164
OG00114287
Title
Denominators
Categories
Title
Measurements
OG000498
OG001214
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
VE
63.0
2-Sided
95
56.6
68.5
VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.
Other
Units
Counts
Participants
OG000272
OG0011185
Title
Denominators
Categories
Baseline SARS-CoV-2 Negative, ID50, Day 1
ParticipantsOG000142
ParticipantsOG0011052
Title
Measurements
OG000NA(NA to NA)All antibody values were below the lower limit of quantification (LLOQ), therefore, no data for assessment.
OG0019.624(9.35 to 9.90)
Baseline SARS-CoV-2 Negative', ID50, Day 29
ParticipantsOG000142
ParticipantsOG0011055
Title
Measurements
OG0009.515(9.00 to 10.06)
OG001
Baseline SARS-CoV-2 Negative', ID50, Day 57
ParticipantsOG000142
ParticipantsOG0011053
Title
Measurements
OG0009.903(8.99 to 10.90)
OG001
Baseline SARS-CoV-2 Negative', ID80, Day 1
ParticipantsOG000142
ParticipantsOG0011052
Title
Measurements
OG000NA(NA to NA)All antibody values were below LLOQ, therefore, no data for assessment.
OG001
Baseline SARS-CoV-2 Negative', ID80, Day 29
ParticipantsOG000142
ParticipantsOG0011055
Title
Measurements
OG0007.279(7.03 to 7.54)
OG001
Baseline SARS-CoV-2 Negative', ID80, Day 57
ParticipantsOG000142
ParticipantsOG0011053
Title
Measurements
OG0007.522(7.00 to 8.09)
OG001
Baseline SARS-CoV-2 Positive, ID50, Day 1
ParticipantsOG000129
ParticipantsOG001130
Title
Measurements
OG00082.519(59.40 to 114.64)
OG001
Baseline SARS-CoV-2 Positive, ID50, Day 29
ParticipantsOG000129
ParticipantsOG001130
Title
Measurements
OG00052.728(39.45 to 70.48)
OG001
Baseline SARS-CoV-2 Positive, ID50, Day 57
ParticipantsOG000130
ParticipantsOG001130
Title
Measurements
OG00047.708(35.41 to 64.28)
OG001
Baseline SARS-CoV-2 Positive, ID80, Day 1
ParticipantsOG000129
ParticipantsOG001130
Title
Measurements
OG00029.580(22.39 to 39.09)
OG001
Baseline SARS-CoV-2 Positive, ID80, Day 29
ParticipantsOG000129
ParticipantsOG001130
Title
Measurements
OG00020.994(16.42 to 26.84)
OG001
Baseline SARS-CoV-2 Positive, ID80, Day 57
ParticipantsOG000130
ParticipantsOG001130
Title
Measurements
OG00019.228(15.03 to 24.60)
OG001
Units
Counts
Participants
OG000271
OG0011182
Title
Denominators
Categories
Baseline SARS-CoV-2 Negative, ID50 Day 29
ParticipantsOG000142
ParticipantsOG0011052
Title
Measurements
OG0001.03(0.97 to 1.09)
OG0015.69(5.29 to 6.12)
Baseline SARS-CoV-2 Negative, ID50 Day 57
ParticipantsOG000142
ParticipantsOG0011050
Title
Measurements
OG0001.07(0.97 to 1.18)
OG001
Baseline SARS-CoV-2, Negative, ID80 Day 29
ParticipantsOG000142
ParticipantsOG0011052
Title
Measurements
OG0001.02(0.98 to 1.05)
OG001
Baseline SARS-CoV-2 Negative, ID80 Day 57
ParticipantsOG000142
ParticipantsOG0011050
Title
Measurements
OG0001.05(0.98 to 1.13)
OG001
Baseline SARS-CoV-2, Positive, ID50 Day 29
ParticipantsOG000128
ParticipantsOG001130
Title
Measurements
OG0000.64(0.56 to 0.73)
OG001
Baseline SARS-CoV-2 Positive, ID50 Day 57
ParticipantsOG000129
ParticipantsOG001130
Title
Measurements
OG0000.59(0.50 to 0.69)
OG001
Baseline SARS-CoV-2 Positive, ID80 Day 29
ParticipantsOG000128
ParticipantsOG001130
Title
Measurements
OG0000.71(0.64 to 0.79)
OG001
Baseline SARS-CoV-2 Positive, ID80 Day 57
ParticipantsOG000129
ParticipantsOG001130
Title
Measurements
OG0000.66(0.57 to 0.75)
OG001
Units
Counts
Participants
OG000272
OG0011185
Title
Denominators
Categories
Baseline SARS-CoV-2 Negative, ID50, Day 29
ParticipantsOG000142
ParticipantsOG0011055
Title
Measurements
OG0000.7(0.0 to 3.9)
OG00181.4(78.9 to 83.7)
Baseline SARS-CoV-2 Negative, ID50, Day 57
ParticipantsOG000142
ParticipantsOG0011053
Title
Measurements
OG0001.4(0.2 to 5.0)
OG001
Baseline SARS-CoV-2 Negative, ID80, Day 29
ParticipantsOG000142
ParticipantsOG0011055
Title
Measurements
OG0000.7(0.0 to 3.9)
OG001
Baseline SARS-CoV-2 Negative, ID80, Day 57
ParticipantsOG000142
ParticipantsOG0011053
Title
Measurements
OG0001.4(0.2 to 5.0)
OG001
Baseline SARS-CoV-2 Positive, ID50, Day 29
ParticipantsOG000129
ParticipantsOG001130
Title
Measurements
OG0000.8(0.0 to 4.3)
OG001
Baseline SARS-CoV-2 Positive, ID50, Day 57
ParticipantsOG000130
ParticipantsOG001130
Title
Measurements
OG0001.6(0.2 to 5.5)
OG001
Baseline SARS-CoV-2 Positive, ID80, Day 29
ParticipantsOG000129
ParticipantsOG001130
Title
Measurements
OG0003.1(0.9 to 7.8)
OG001
Baseline SARS-CoV-2 Positive, ID80, Day 57
ParticipantsOG000130
ParticipantsOG001130
Title
Measurements
OG0002.3(0.5 to 6.6)
OG001
700
Title
Denominators
Categories
Pre-booster (Baseline)
ParticipantsOG000700
Title
Measurements
OG000163.848(147.977 to 181.421)
BD Day 29
ParticipantsOG000677
Title
Measurements
OG0008122.189(7603.021 to 8676.808)
BD Day 181
ParticipantsOG000610
Title
Measurements
OG0002951.123(2701.648 to 3223.636)
670
Title
Denominators
Categories
BD Day 29
ParticipantsOG000670
Title
Measurements
OG00094.5(92.5 to 96.1)
BD Day 181
ParticipantsOG000591
Title
Measurements
OG00089.2(86.4 to 91.6)
636
OG001680
Title
Denominators
Categories
Part C BD Day 29
ParticipantsOG000636
ParticipantsOG0010
Title
Measurements
OG0007739.680(7240.926 to 8272.789)
Part A Day 57
ParticipantsOG0000
ParticipantsOG001680
Title
Measurements
OG0011111.274(1041.684 to 1185.513)
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 GMC 28 days following the booster dose (BD-Day 29) compared with 28 days following second dose (Part A-Day 57).
Ratio of GMC
6.996
2-Sided
95
6.509
7.520
Non-Inferiority
Non-inferiority of a booster as compared with mRNA-1273 after second dose based on Ratio of GMC is demonstrated if lower bound of 95% CI of Ratio of GMC ≥ 0.67.
636
OG001680
Title
Denominators
Categories
Part C BD Day 29
ParticipantsOG000636
ParticipantsOG0010
Title
Measurements
OG000100(99.4 to 100)
Part A Day 57
ParticipantsOG0000
ParticipantsOG001680
Title
Measurements
OG00198.8(97.7 to 99.5)
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
Seroresponse 28 days following the booster dose (BD-Day 29) compared with 28 days following second dose (Part A-Day 57)
Difference in Seroresponse
0.9
2-Sided
95
0.1
1.8
95% CI were calculated using adjusted Wald method for the paired binary data.
Non-Inferiority
Non-inferiority of a booster as compared with mRNA-1273 after second dose based on SRR difference is demonstrated if lower bound of 95% CI of SRR difference > -10%.