A Study to Evaluate the Safety and Immunogenicity of IVX-... | NCT05903183 | Trialant
NCT05903183
Sponsor
Icosavax, Inc.
Status
Completed
Last Update Posted
Dec 5, 2025Actual
Enrollment
264Actual
Phase
Phase 2
Conditions
Healthy
Interventions
IVX-A12
IVX-A12
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT05903183
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ICVX-12-201
Secondary IDs
Not provided
Brief Title
A Study to Evaluate the Safety and Immunogenicity of IVX-A12 in Participants of 60 to 85 Years of Age
Official Title
A Phase 2a Randomized, Observer-blind, Placebo-controlled, Dosage Optimization, Multi-center Clinical Trial to Evaluate the Safety and Immunogenicity of IVX-A12, a Respiratory Syncytial Virus and Human Metapneumovirus Bivalent Combination Virus-like Particle Protein Subunit Vaccine, in Adults 60 to 85 Years of Age
Acronym
Not provided
Organization
Icosavax, Inc.INDUSTRY
Status Module
Record Verification Date
Nov 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 15, 2023Actual
Primary Completion Date
Jun 5, 2023Actual
Completion Date
Oct 25, 2024Actual
First Submitted Date
Jun 5, 2023
First Submission Date that Met QC Criteria
Jun 5, 2023
First Posted Date
Jun 15, 2023Actual
Results Waived
Not provided
Results First Submitted Date
Nov 24, 2025
Results First Submitted that Met QC Criteria
Nov 24, 2025
Results First Posted Date
Dec 5, 2025Actual
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
Nov 24, 2025
Last Update Posted Date
Dec 5, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Icosavax, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary purpose of the study is to assess the safety, tolerability and immunogenicity of a bivalent respiratory syncytial virus (RSV)/human metapneumovirus (hMPV) virus-like particle (VLP) candidate vaccine (IVX-A12) compared to placebo, when administered as a single-dose regimen in healthy older adults 60 to 85 years of age.
Detailed Description
The IVX-A12 Phase 2a clinical trial is a randomized, observer-blind, placebo-controlled, dosage optimization, multi-center trial to evaluate the safety and immunogenicity of a single intramuscular (IM) dose of IVX-A12, with or without adjuvant, in adults 60 to 85 years of age.
Participants will be administered a single shot of IVX-A12, at specified dosage levels, or placebo. The overall duration of the study is up to 1 year (12 months). A subset of participants will be followed for an additional 12 months for a total duration of 24 months.
Conditions Module
Conditions
Healthy
Keywords
Respiratory syncytial virus (RSV)
Human metapneumovirus (hMPV)
Bivalent virus-like particle protein subunit vaccine
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
264Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
IVX-A12 Vaccine Formulation 1
Experimental
Participants will receive a single dose of IVX-A12 intramuscular (IM) injection on Day 0.
Biological: IVX-A12
IVX-A12 Vaccine Formulation 2
Experimental
Participants will receive a single dose of IVX-A12 IM injection on Day 0.
Biological: IVX-A12
Placebo
Placebo Comparator
Participants will receive a single dose of placebo IM injection on Day 0.
Biological: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
IVX-A12
Biological
IVX-A12 without adjuvant
IVX-A12 Vaccine Formulation 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Solicited Local Adverse Reactions (ARs) and Systemic ARs
Solicited local ARs include pain, tenderness, erythema, and swelling. Solicited systemic ARs include headache, chills, fatigue, myalgia, arthralgia, vomiting, diarrhea, and fever.
From Day 0 to Day 6
Number of Participants With Unsolicited Adverse Events
An unsolicited AE is an AE that was not solicited using the post-vaccination diary and that was spontaneously communicated by a participant.
From Day 0 to Day 28
Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb)
Model-adjusted GMT and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 titer at Day 28 with independent variables of log2 baseline titer, age group, and treatment group.
At Day 28
Model-adjusted Geometric Mean Concentrations (GMC) for RSV and hMPV Prefusion F Protein-specific IgG Antibodies (Ab)
Model-adjusted GMC and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 concentration at Day 28 with independent variables of log2 baseline concentration, age group, and treatment group.
At Day 28
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in NAb titer versus baseline (Day 0).
From Day 0 (pre-vaccination) up to Day 28 post-vaccination
Percentage of Participants With >=4-fold Increase in RSV and hMPV-specific IgG Ab Concentration
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Serious Adverse Event (SAE), Medically-attended Adverse Events (MAAEs), and AEs Leading to Trial Withdrawal
An SAE is defined as any untoward medical occurrence that met one or more of the following: resulted in death; was immediately life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly or birth defect in the offspring of a subject; was an important and significant medical event that might have jeopardized the participant or required medical intervention to prevent one of the aforementioned outcomes. Any AESI occurring during the trial will be categorized and reported as an SAE. These AESIs include anaphylaxis, thrombocytopenia, and other potential immune-mediate conditions (including Guillain Barre syndrome). MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional, including visits to an emergency department, but not fulfilling seriousness criteria.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female participants, who must be in stable health based on medical history, vital signs, physical examination, and laboratory evaluation prior to vaccination, in the investigator's clinical judgment
Participants may have ongoing chronic conditions (comorbidities such as hypertension, congestive heart failure, chronic obstructive pulmonary disease, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism) who are, in the investigator's opinion, medically compensated and without recent exacerbation within the prior 3 months
Participants able to voluntarily give written informed consent and can comply with trial procedures including follow-up for approximately 12 months after vaccination
Body mass index 17 to less than (<) 40 kilograms per square meter (kg/m^2) at screening
Before randomization, female participants must be unable to conceive (example, menopausal, that is, 12 consecutive months without menstruation, hysterectomy, oophorectomy, etc.) and not intending to conceive by any method
Participants must agree not to donate blood from the time of vaccination through 3 months after vaccination
Participants must be willing to provide verifiable identification and have the means to be contacted and to contact the investigator or the site's staff during the entire clinical trial
Exclusion Criteria:
Participants with moderate or severe liver disease, metastatic solid tumor, and acquired immunodeficiency syndrome (AIDS) are to be excluded. In addition, participants with underlying significant illness or condition(s) or ongoing treatment that, in the opinion of the investigator, could (i) interfere with the conduct of the trial, (ii) pose an unacceptable risk to the participant in this trial, (iii) interfere with the participant's ability to comply with the trial procedures or abide by the procedures
Older adults who meet frail elderly criteria (older persons with medical, nutritional, cognitive, emotional, or activity impairments, as defined by the Dalhousie Clinical Frailty Score greater than or equal to [>=]4)
Prior receipt of any licensed or investigational RSV or hMPV vaccine within the past 12 months
Prior receipt of another investigational medicinal product (IMP; trial drug, biologic, or device) not authorized for use in the United States of America (USA) and European Union within the past 3 months
Laboratory-confirmed RSV or hMPV infection within 12 months prior to enrollment
Currently enrolled or plan to participate in another clinical trial with an investigational agent (including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication) to be received during the trial period
History of malignancy within 5 years before screening not in the following categories: (i) participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator, (ii) participants with a history of malignancy within 5 years before screening, with minimal risk of recurrence per investigator's judgment, can be enrolled
Acute illness, with or without fever at the time of planned vaccination
History of hypersensitivity or serious adverse reactions to vaccines, such as anaphylaxis or angioedema, or any known allergies to any component of the IVX-121 and/or IVX-241 vaccine, or hypersensitivity to latex
Abnormal function of the immune system resulting from clinical conditions including chronic administration of systemic corticosteroids (oral/intravenous/IM at a daily dose equivalent of greater than (>) 20 milligram (mg) prednisone in a period of more than 14 days), or administration of immunosuppressive chemotherapy, biologics, or radiotherapy within the past 3 months prior to planned vaccination
Participants who have received treatment with immunoglobulins or other biologics, such as immunosuppressive therapies expected to modify immune response to vaccination (including monoclonal antibodies [MAbs] for chronic underlying conditions) within the past 3 months prior to planned vaccination
Trial personnel as an immediate family or household member
For licensed vaccines:
Receipt of licensed inactivated vaccines (including seasonal influenza vaccine) within 14 days prior to trial vaccine administration on Day 0, or licensed replicating vaccines such as ribonucleic acid (RNA) or live-attenuated virus vaccines within 30 days prior to Day 0
Receipt of licensed vaccines is permitted after completion of the Day 28 visit
Receipt of any licensed Coronavirus Disease-2019 (COVID-19) vaccines is permitted if dosing regimen completed within 21 days prior to Day 0 or after completion of the Day 28 visit.
A total 264 participants were enrolled and randomized to receive vaccinations in this study. The study has a Main Trial part and Observation Extension Trial part.
Recruitment Details
Participants were recruited at 10 investigative sites in the United States.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
FG001
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in Ab concentration versus baseline (Day 0).
From Day 0 (pre-vaccination) up to Day 28 post-vaccination
Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers
GMFR is defined as the geometric mean of the ratio of NAb titer at specified timepoints after vaccination divided by baseline (Day 0) titer.
From Day 0 (pre-vaccination) up to Day 28 post-vaccination
Geometric Mean Fold Rise (GMFR) in Serum for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
GMFR is defined as the geometric mean of the ratio of Ab concentration at specified timepoints after vaccination divided by baseline (Day 0) concentration.
From Day 0 (pre-vaccination) up to Day 28 post-vaccination
From Day 0 up to the end of study (up to Day 365)
Number of Participants With Mild, Moderate, or Severe Lower Respiratory Tract Illness (LRTI) Caused by RSV and/or hMPV
Data is summarized as the number of subjects with at least one LRTI event (mild, moderate, or severe) by treatment group.
From Day 0 up to Day 365 (end of study)
Number of Participants With Mild, Moderate, or Severe LRTI Cases Not Caused by RSV or hMPV
Data is summarized as the number of subjects with at least one LRTI event (mild, moderate, or severe) by treatment group.
From Day 0 up to Day 365 (end of study)
Number of Participants With Clinically Significant Safety Laboratory Parameters
At Screening, Days 0, 7 and 28
Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb
Model-adjusted GMT and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 titer at each post-baseline timepoint with independent variables of log2 baseline titer, age group, and treatment group.
At Days 180 and 365
Model-Adjusted GMCs for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
Model-adjusted GMC and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 concentration at each post-baseline timepoint with independent variables of log2 baseline concentration, age group, and treatment group.
At Days 180, and 365
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in NAb titer versus baseline (Day 0).
From Day 0 (pre-vaccination) up to Day 180 and Day 365 post-vaccination
Percentage of Participants With >=4-fold Increase in RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in Ab concentration versus baseline (Day 0).
From Day 0 (pre-vaccination) up to Days 180, and 365 post-vaccination
Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
Proportion of participants with non-missing results at the specified visit achieving a 8-fold or greater increase in NAb titer versus baseline (Day 0).
From Day 0 (pre-vaccination) up to Days 28, 180, and 365 post-vaccination
GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
GMFR is defined as the geometric mean of the ratio of Ab concentration at specified timepoints after vaccination divided by baseline (Day 0) concentration.
From Day 0 (pre-vaccination) up to Day 180 and Day 365 post-vaccination
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
The median, as well as 25th and 75th percentiles of serum NAb titers and IgG Ab concentrations are summarized at specified timepoints.
Participants who received a single dose of 150 mcg IVX-A12, IM injection on Day 1 in Main Trial part were enrolled and observed in Extension part.
FG004
Observational Extension Part: Placebo
Participants who received matching placebo on Day 1 in Main Trial part were enrolled and observed in Extension part.
FG000102 subjects
FG001109 subjects
FG00253 subjects
FG0030 subjects
FG0040 subjects
Safety Set
FG000103 subjectsOne participant was randomized in IVX-A12 150 mcg with MF59 group but was treated in IVX-A12 150 mcg group.
FG001108 subjectsOne participant was randomized in IVX-A12 150 mcg with MF59 group but was treated in IVX-A12 150 mcg group.
FG00253 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG00099 subjects
FG001107 subjects
FG00251 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG0003 subjects
FG0012 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Other
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Observation Extension Part (144 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00335 subjectsParticipants who completed the main part and gave consent to enroll in the extension part were included.
FG00420 subjectsParticipants who completed the main part and gave consent to enroll in the extension part were included.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00335 subjects
FG004
Type
Comment
Reasons
Sponsor's decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
The Full Analysis Set (FAS) includes all randomized participants who received a dose of IVX-A12 or placebo.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
BG001
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
BG002
Main Trial Part: Placebo
Participants received matching placebo on Day 1.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000102
BG001109
BG00253
BG003264
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
BG00069.2± 6.05
BG00169.3± 5.83
BG00268.8± 5.79
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00055
BG00165
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00019
BG00123
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Solicited Local Adverse Reactions (ARs) and Systemic ARs
Solicited local ARs include pain, tenderness, erythema, and swelling. Solicited systemic ARs include headache, chills, fatigue, myalgia, arthralgia, vomiting, diarrhea, and fever.
The Safety Set includes all participants who received any amount of IVX-A12 or placebo.
Posted
Count of Participants
Participants
From Day 0 to Day 6
ID
Title
Description
OG000
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
OG001
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
OG002
Main Trial Part: Placebo
Participants received matching placebo on Day 1.
Units
Counts
Participants
OG000103
OG001108
OG00253
Title
Denominators
Categories
Solicited Local Adverse Reactions
Title
Measurements
OG00046
OG00168
OG0025
Solicited Systemic Adverse Reactions
Primary
Number of Participants With Unsolicited Adverse Events
An unsolicited AE is an AE that was not solicited using the post-vaccination diary and that was spontaneously communicated by a participant.
The Safety Set includes all participants who received any amount of IVX-A12 or placebo.
Posted
Count of Participants
Participants
From Day 0 to Day 28
ID
Title
Description
OG000
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
OG001
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
OG002
Main Trial Part: Placebo
Participants received matching placebo on Day 1.
Units
Counts
Participants
Primary
Model-adjusted Geometric Mean Titers (GMT) for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific Neutralizing Antibodies (NAb)
Model-adjusted GMT and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 titer at Day 28 with independent variables of log2 baseline titer, age group, and treatment group.
The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS.
Posted
Geometric Mean
95% Confidence Interval
MN50 titer
At Day 28
ID
Title
Description
OG000
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
OG001
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
OG002
Main Trial Part: Placebo
Participants received matching placebo on Day 1.
Units
Primary
Model-adjusted Geometric Mean Concentrations (GMC) for RSV and hMPV Prefusion F Protein-specific IgG Antibodies (Ab)
Model-adjusted GMC and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 concentration at Day 28 with independent variables of log2 baseline concentration, age group, and treatment group.
The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS.
Posted
Geometric Mean
95% Confidence Interval
ELISA units per milliliter (EU/mL)
At Day 28
ID
Title
Description
OG000
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
OG001
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
OG002
Main Trial Part: Placebo
Participants received matching placebo on Day 1.
Primary
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in NAb titer versus baseline (Day 0).
The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS.
Posted
Number
percentage of participants
From Day 0 (pre-vaccination) up to Day 28 post-vaccination
ID
Title
Description
OG000
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
OG001
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
OG002
Main Trial Part: Placebo
Participants received matching placebo on Day 1.
Units
Counts
Primary
Percentage of Participants With >=4-fold Increase in RSV and hMPV-specific IgG Ab Concentration
Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in Ab concentration versus baseline (Day 0).
The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS.
Posted
Number
percentage of participants
From Day 0 (pre-vaccination) up to Day 28 post-vaccination
ID
Title
Description
OG000
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
OG001
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
OG002
Main Trial Part: Placebo
Participants received matching placebo on Day 1.
Units
Counts
Primary
Geometric Mean Fold Rise (GMFR) in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-Specific NAb Titers
GMFR is defined as the geometric mean of the ratio of NAb titer at specified timepoints after vaccination divided by baseline (Day 0) titer.
The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS.
Posted
Geometric Mean
95% Confidence Interval
fold rise
From Day 0 (pre-vaccination) up to Day 28 post-vaccination
ID
Title
Description
OG000
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
OG001
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
OG002
Main Trial Part: Placebo
Participants received matching placebo on Day 1.
Units
Counts
Primary
Geometric Mean Fold Rise (GMFR) in Serum for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
GMFR is defined as the geometric mean of the ratio of Ab concentration at specified timepoints after vaccination divided by baseline (Day 0) concentration.
The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS.
Posted
Geometric Mean
95% Confidence Interval
fold rise
From Day 0 (pre-vaccination) up to Day 28 post-vaccination
ID
Title
Description
OG000
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
OG001
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
OG002
Main Trial Part: Placebo
Participants received matching placebo on Day 1.
Units
Secondary
Number of Participants With Serious Adverse Event (SAE), Medically-attended Adverse Events (MAAEs), and AEs Leading to Trial Withdrawal
An SAE is defined as any untoward medical occurrence that met one or more of the following: resulted in death; was immediately life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly or birth defect in the offspring of a subject; was an important and significant medical event that might have jeopardized the participant or required medical intervention to prevent one of the aforementioned outcomes. Any AESI occurring during the trial will be categorized and reported as an SAE. These AESIs include anaphylaxis, thrombocytopenia, and other potential immune-mediate conditions (including Guillain Barre syndrome). MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional, including visits to an emergency department, but not fulfilling seriousness criteria.
The Safety Set includes all participants who received any amount of IVX-A12 or placebo.
Posted
Count of Participants
Participants
From Day 0 up to the end of study (up to Day 365)
ID
Title
Description
OG000
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
OG001
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
Secondary
Number of Participants With Mild, Moderate, or Severe Lower Respiratory Tract Illness (LRTI) Caused by RSV and/or hMPV
Data is summarized as the number of subjects with at least one LRTI event (mild, moderate, or severe) by treatment group.
The Safety Set includes all participants who received any amount of IVX-A12 or placebo.
Posted
Count of Participants
Participants
From Day 0 up to Day 365 (end of study)
ID
Title
Description
OG000
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
OG001
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
OG002
Main Trial Part: Placebo
Participants received matching placebo on Day 1.
Units
Counts
Participants
Secondary
Number of Participants With Mild, Moderate, or Severe LRTI Cases Not Caused by RSV or hMPV
Data is summarized as the number of subjects with at least one LRTI event (mild, moderate, or severe) by treatment group.
The Safety Set includes all participants who received any amount of IVX-A12 or placebo.
Posted
Count of Participants
Participants
From Day 0 up to Day 365 (end of study)
ID
Title
Description
OG000
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
OG001
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
OG002
Main Trial Part: Placebo
Participants received matching placebo on Day 1.
Units
Counts
Participants
Secondary
Number of Participants With Clinically Significant Safety Laboratory Parameters
The Safety Set includes all participants who received any amount of IVX-A12 or placebo.
Posted
Number
participants
At Screening, Days 0, 7 and 28
ID
Title
Description
OG000
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
OG001
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
OG002
Main Trial Part: Placebo
Participants received matching placebo on Day 1.
Units
Counts
Participants
OG000
Secondary
Model-Adjusted GMTs for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb
Model-adjusted GMT and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 titer at each post-baseline timepoint with independent variables of log2 baseline titer, age group, and treatment group.
The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS. Here 'n' refers to number of participants analyzed at given timepoints.
Posted
Geometric Mean
95% Confidence Interval
MN50 titer
At Days 180 and 365
ID
Title
Description
OG000
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
OG001
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
OG002
Main Trial Part: Placebo
Participants received matching placebo on Day 1.
Secondary
Model-Adjusted GMCs for RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
Model-adjusted GMC and corresponding 95% CI were derived from an analysis of covariance (ANCOVA) model of log2 concentration at each post-baseline timepoint with independent variables of log2 baseline concentration, age group, and treatment group.
The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS. Here 'n' refers to number of participants analyzed at given timepoints.
Posted
Geometric Mean
95% Confidence Interval
ELISA units per milliliter (EU/mL)
At Days 180, and 365
ID
Title
Description
OG000
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
OG001
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
OG002
Main Trial Part: Placebo
Participants received matching placebo on Day 1.
Secondary
Percentage of Participants With a >=4-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in NAb titer versus baseline (Day 0).
The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS. Here 'n' refers to number of participants analyzed at given timepoints.
Posted
Number
percentage of participants
From Day 0 (pre-vaccination) up to Day 180 and Day 365 post-vaccination
ID
Title
Description
OG000
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
OG001
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
OG002
Main Trial Part: Placebo
Participants received matching placebo on Day 1.
Secondary
Percentage of Participants With >=4-fold Increase in RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
Proportion of participants with non-missing results at the specified visit achieving a 4-fold or greater increase in Ab concentration versus baseline (Day 0).
The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS. Here 'n' refers to number of participants analyzed at given timepoints.
Posted
Number
percentage of participants
From Day 0 (pre-vaccination) up to Days 180, and 365 post-vaccination
ID
Title
Description
OG000
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
OG001
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
OG002
Main Trial Part: Placebo
Participants received matching placebo on Day 1.
Secondary
Percentage of Participants With a >=8-fold Increase in Serum RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers
Proportion of participants with non-missing results at the specified visit achieving a 8-fold or greater increase in NAb titer versus baseline (Day 0).
The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS. Here 'n' refers to number of participants analyzed at given timepoints.
Posted
Number
percentage of participants
From Day 0 (pre-vaccination) up to Days 28, 180, and 365 post-vaccination
ID
Title
Description
OG000
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
OG001
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
OG002
Main Trial Part: Placebo
Participants received matching placebo on Day 1.
Secondary
GMFR in Serum for RSV-A, RSV-B, hMPV-A, and hMPV-B-specific NAb Titers and RSV and hMPV Prefusion F Protein-specific IgG Ab Concentrations
GMFR is defined as the geometric mean of the ratio of Ab concentration at specified timepoints after vaccination divided by baseline (Day 0) concentration.
The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS. Here 'n' refers to number of participants analyzed at given timepoints.
Posted
Geometric Mean
95% Confidence Interval
fold rise
From Day 0 (pre-vaccination) up to Day 180 and Day 365 post-vaccination
ID
Title
Description
OG000
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
OG001
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
OG002
Main Trial Part: Placebo
Participants received matching placebo on Day 1.
Secondary
Reverse Cumulative Distribution (RCD) Curve of Serum NAb Titers and IgG Ab Concentrations
The median, as well as 25th and 75th percentiles of serum NAb titers and IgG Ab concentrations are summarized at specified timepoints.
The PPS includes all participants in the FAS who received a dose of IVX-A12 or placebo and have no major protocol deviations, which may exclude participants from PPS. Here 'n' refers to number of participants analyzed at given timepoints.
Posted
Median
Inter-Quartile Range
MN50 titer
At Days 28, 180, and 365 post-vaccination
ID
Title
Description
OG000
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
OG001
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
OG002
Main Trial Part: Placebo
Participants received matching placebo on Day 1.
Units
Time Frame
From study start to end of observational extension part (up to Day 509)
Description
Not provided
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
Main Trial Part: IVX-A12 150 mcg
Participants received a single dose of 150 mcg IVX-A12, IM injection on Day 1.
1
103
5
103
75
103
EG001
Main Trial Part: IVX-A12 150 mcg With MF59
Participants received a single dose of 150 mcg IVX-A12 adjuvanted with MF59, IM injection on Day 1.
0
108
3
108
81
108
EG002
Main Trial Part: Placebo
Participants received matching placebo on Day 1.
0
53
1
53
42
53
EG003
Observational Extension Part: IVX-A12 150 mcg
Participants who received a single dose of 150 mcg IVX-A12, IM injection on Day 1 in Main Trial part were enrolled and observed in Extension part.
0
35
1
35
3
35
EG004
Observational Extension Part: Placebo
Participants who received matching placebo on Day 1 in Main Trial part were enrolled and observed in Extension part.
0
20
0
20
1
20
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abscess limb
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG0030 affected35 at risk
EG0040 affected20 at risk
Pneumonia
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Pneumonia staphylococcal
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Cerebellar stroke
Nervous system disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Seizure
Nervous system disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0010 affected108 at risk
EG0021 affected53 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA version 26.0
Systematic Assessment
EG0002 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Sudden death
General disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Stag horn calculus
Renal and urinary disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Rhinorrhea
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.0
Systematic Assessment
EG00010 affected103 at risk
EG00110 affected108 at risk
EG0026 affected53 at risk
EG0030 affected35 at risk
EG004
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.0
Systematic Assessment
EG00011 affected103 at risk
EG00118 affected108 at risk
EG0027 affected53 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.0
Systematic Assessment
EG0008 affected103 at risk
EG0019 affected108 at risk
EG0026 affected53 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.0
Systematic Assessment
EG0006 affected103 at risk
EG0019 affected108 at risk
EG0026 affected53 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.0
Systematic Assessment
EG0005 affected103 at risk
EG00110 affected108 at risk
EG0024 affected53 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG00011 affected103 at risk
EG00117 affected108 at risk
EG0028 affected53 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0009 affected103 at risk
EG0018 affected108 at risk
EG0025 affected53 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA version 26.0
Systematic Assessment
EG00010 affected103 at risk
EG00111 affected108 at risk
EG0024 affected53 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 26.0
Systematic Assessment
EG0004 affected103 at risk
EG0015 affected108 at risk
EG0021 affected53 at risk
EG003
Headache
Nervous system disorders
MedDRA version 26.0
Systematic Assessment
EG0008 affected103 at risk
EG0019 affected108 at risk
EG0028 affected53 at risk
EG003
Fatigue
General disorders
MedDRA version 26.0
Systematic Assessment
EG0008 affected103 at risk
EG00113 affected108 at risk
EG0027 affected53 at risk
EG003
Diarrhea
Gastrointestinal disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0016 affected108 at risk
EG0020 affected53 at risk
EG003
Blood pressure increased
Investigations
MedDRA version 26.0
Systematic Assessment
EG0002 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0015 affected108 at risk
EG0022 affected53 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 26.0
Systematic Assessment
EG0008 affected103 at risk
EG0019 affected108 at risk
EG0020 affected53 at risk
EG003
COVID-19
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG00013 affected103 at risk
EG00115 affected108 at risk
EG0029 affected53 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0007 affected103 at risk
EG00112 affected108 at risk
EG0025 affected53 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0006 affected103 at risk
EG0012 affected108 at risk
EG0022 affected53 at risk
EG003
Sinusitis
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0004 affected103 at risk
EG0013 affected108 at risk
EG0021 affected53 at risk
EG003
Cellulitis
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0003 affected103 at risk
EG0013 affected108 at risk
EG0020 affected53 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0005 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Bronchitis
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0002 affected103 at risk
EG0012 affected108 at risk
EG0020 affected53 at risk
EG003
Influenza
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0002 affected103 at risk
EG0012 affected108 at risk
EG0020 affected53 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0003 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0002 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0012 affected108 at risk
EG0020 affected53 at risk
EG003
Tooth infection
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0012 affected108 at risk
EG0020 affected53 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0021 affected53 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0002 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Conjunctivitis bacterial
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Ear infection
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0002 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Fungal infection
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Gingivitis
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
HCoV-OC43 infection
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0021 affected53 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0002 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Abscess limb
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Bronchitis viral
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Coronavirus infection
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Enterocolitis bacterial
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0010 affected108 at risk
EG0021 affected53 at risk
EG003
Eye infection
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Folliculitis
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Gingival abscess
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0010 affected108 at risk
EG0021 affected53 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Hordeolum
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Laryngitis
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Metapneumovirus infection
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Periodontitis
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0010 affected108 at risk
EG0021 affected53 at risk
EG003
Salmonellosis
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.0
Systematic Assessment
EG0005 affected103 at risk
EG0013 affected108 at risk
EG0023 affected53 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.0
Systematic Assessment
EG0002 affected103 at risk
EG0011 affected108 at risk
EG0021 affected53 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.0
Systematic Assessment
EG0002 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0021 affected53 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Oropharyngeal cobble stone mucosa
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Obstructive sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
HCoV-229E infection
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Lyme disease
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0010 affected108 at risk
EG0021 affected53 at risk
EG003
Otitis externa
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Sialoadenitis
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0013 affected108 at risk
EG0020 affected53 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA version 26.0
Systematic Assessment
EG0002 affected103 at risk
EG0014 affected108 at risk
EG0020 affected53 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 26.0
Systematic Assessment
EG0004 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0021 affected53 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0010 affected108 at risk
EG0021 affected53 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Sacral pain
Musculoskeletal and connective tissue disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0010 affected108 at risk
EG0021 affected53 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Trigger finger
Musculoskeletal and connective tissue disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Pyrexia
General disorders
MedDRA version 26.0
Systematic Assessment
EG0002 affected103 at risk
EG0012 affected108 at risk
EG0022 affected53 at risk
EG003
Influenza like illness
General disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0013 affected108 at risk
EG0021 affected53 at risk
EG003
Chest pain
General disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0010 affected108 at risk
EG0021 affected53 at risk
EG003
Chills
General disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Effusion
General disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0010 affected108 at risk
EG0021 affected53 at risk
EG003
Injection site pain
General disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Pain
General disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0010 affected108 at risk
EG0021 affected53 at risk
EG003
Sciatica
Nervous system disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0011 affected108 at risk
EG0021 affected53 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Tardive dyskinesia
Nervous system disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Trigeminal neuralgia
Nervous system disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA version 26.0
Systematic Assessment
EG0003 affected103 at risk
EG0013 affected108 at risk
EG0023 affected53 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA version 26.0
Systematic Assessment
EG0002 affected103 at risk
EG0012 affected108 at risk
EG0021 affected53 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0013 affected108 at risk
EG0020 affected53 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA version 26.0
Systematic Assessment
EG0002 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0010 affected108 at risk
EG0021 affected53 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0010 affected108 at risk
EG0021 affected53 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Device physical property issue
Product Issues
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0010 affected108 at risk
EG0021 affected53 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Type V hyperlipidaemia
Congenital, familial and genetic disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Breast cyst
Reproductive system and breast disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Menopausal symptoms
Reproductive system and breast disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Macular degeneration
Eye disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Glaucoma
Eye disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0010 affected108 at risk
EG0021 affected53 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Thyroid mass
Endocrine disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Depression
Psychiatric disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0021 affected53 at risk
EG003
Alcohol abuse
Psychiatric disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Claustrophobia
Psychiatric disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Generalised anxiety disorder
Psychiatric disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0021 affected53 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Bundle branch block left
Cardiac disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0010 affected108 at risk
EG0021 affected53 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0012 affected108 at risk
EG0020 affected53 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0011 affected108 at risk
EG0020 affected53 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0012 affected108 at risk
EG0021 affected53 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 26.0
Systematic Assessment
EG0000 affected103 at risk
EG0010 affected108 at risk
EG0022 affected53 at risk
EG003
Bowen's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 26.0
Systematic Assessment
EG0001 affected103 at risk
EG0010 affected108 at risk
EG0020 affected53 at risk
EG003
Mantle cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)