A Study on the Safety, Reactogenicity and Immune Response... | NCT05446740 | Trialant
NCT05446740
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Mar 10, 2026Actual
Enrollment
324Actual
Phase
Phase 1
Conditions
Influenza, Human
Interventions
GSK4382276A Dose level 1
GSK4382276A Dose level 2
GSK4382276A Dose level 3
GSK4382276A Dose level 4
GSK4382276A Dose level 5
GSK4382276A Dose level 6
GSK4382276A Dose level 7
GSK4382276A Dose level 8
GSK4382276A Dose level 9
GSK4382276A Dose level 10
FDQ21A-NH
FDQ22A-NH
Countries
Belgium
Canada
Spain
Protocol Section
Identification Module
NCT ID
NCT05446740
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
217895
Secondary IDs
ID
Type
Description
Link
2022-000489-17
EudraCT Number
Brief Title
A Study on the Safety, Reactogenicity and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults
Official Title
A Phase 1 Randomized, Dose Escalation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of an mRNA-based Monovalent Influenza Vaccine Candidate in Healthy Younger and Older Adults
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Feb 2026
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
Aug 9, 2022Actual
Primary Completion Date
Mar 26, 2024Actual
Completion Date
Mar 26, 2024Actual
First Submitted Date
Jun 28, 2022
First Submission Date that Met QC Criteria
Jul 4, 2022
First Posted Date
Jul 7, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Sep 26, 2025
Results First Submitted that Met QC Criteria
Feb 17, 2026
Results First Posted Date
Mar 10, 2026Actual
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
Feb 17, 2026
Last Update Posted Date
Mar 10, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Name
Class
CureVac
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this first-time-in-human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based monovalent vaccine (GSK4382276A) candidate against influenza in healthy younger adults (YA) and older adults (OA).
Detailed Description
Not provided
Conditions Module
Conditions
Influenza, Human
Keywords
Influenza
Safety
Reactogenicity
Immunogenicity
mRNA vaccine
Healthy younger adults
Healthy older adults
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
324Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Flu mRNA_Dose level 1_Younger adults (YA)
Experimental
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
Biological: GSK4382276A Dose level 1
Flu mRNA_Dose level 2 _YA
Experimental
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
Biological: GSK4382276A Dose level 2
Flu mRNA_Dose level 3_YA
Experimental
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
Biological: GSK4382276A Dose level 3
Flu mRNA_Dose level 4_YA
Experimental
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
Biological: GSK4382276A Dose level 4
Flu mRNA_Dose level 5_YA
Experimental
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GSK4382276A Dose level 1
Biological
Single dose of intervention administered at Day 1
Flu mRNA_Dose level 1_Younger adults (YA)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Reporting Any Solicited Administration Site Events
Assessed solicited administration site events included pain, erythema/redness, swelling and Lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Day 1 to Day 7
Number of Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events included fever, chills, headache, myalgia, arthralgia and fatigue. Any = occurrence of the symptom regardless of intensity grade.
Day 1 to Day 7
Number of Participants Reporting Any Unsolicited Adverse Events (AEs)
An unsolicited AEs is an AEs that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs must have been communicated by a participant who has signed the informed consent or through his/her caregiver. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the symptom regardless of intensity grade or relation to study vaccination.
Day 1 to Day 28
Number of Participants Reporting Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or resulted in abnormal pregnancy outcomes, or in other situations that were considered serious per medical or scientific judgment.
Day 1 to Day 183
Number of Participants Reporting AEs of Special Interest (AESIs)
Secondary Outcomes
Measure
Description
Time Frame
GMT of Anti-vaccine Antibody Titers
At Day 62 and Day 183
GMI of Anti-vaccine Antibody Titers From Day 1 (Baseline) to Day 62
GMI is defined as the geometric mean of the ratios of the post-dose anti-vaccine antibody titer over the Day 1 anti-vaccine antibody titer.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
A male or female between and including 18 and 45 years of age (YAs) or between and including 60 and 80 years of age (OAs) at the time of the study intervention administration. The age of sentinel participants in OA category will be limited to maximum 70 years.
Healthy or medically stable participants as established by medical history, safety laboratory assessments and clinical examination.
Body mass index >= 18 kg/m^2 and <= 32 kg/m^2.
Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written informed consent obtained from the participant prior to performing any study-specific procedure.
Female participants of non-childbearing potential may be enrolled in the study.
Female participants of childbearing potential may be enrolled in the study if the participant:
has practiced adequate contraception for 28 days prior to study intervention administration, and
has a negative pregnancy test on the day of study intervention administration, and
has agreed to continue adequate contraception for at least 1 month after study intervention administration.
Exclusion Criteria:
Medical conditions
Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or review of the participant's medical record.
Any clinically significant hematological coagulation or urine analysis laboratory abnormality.
* The investigator should use his/her clinical judgement to decide which abnormalities are clinically significant.
Current or past malignancy, unless completely resolved without sequelae for >5 years.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection, based on medical history and physical examination (no laboratory testing required).
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention (including latex, poly-ethylene-glycol, egg protein and aminoglycoside antibiotics).
Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
Significant exposure to persons with influenza or laboratory-confirmed SARS-CoV-2 within 7 days prior to Visit 1 (Day 1) and for whom a SARS-CoV-2 PCR test has not (yet) been confirmed as negative.
Prior/Concomitant therapy
Administration of seasonal influenza vaccine within 180 days before enrollment or planned administration up to Visit 4 (Day 29).
Administration of a vaccine not foreseen by the study protocol in the period starting 28 days before the study intervention administration, or planned administration within 28 days after the study intervention administration*, with the exception of vaccines authorized or approved for the prevention of COVID-19 (regardless of the type of vaccine).
*In case emergency mass vaccination for an unforeseen public health threat is organized by public health authorities outside the routine immunization program, the time period described above can be reduced to 7 days, if necessary, for that mass vaccination vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.
Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention during the period beginning 30 days before the study intervention administration, or their planned use during the study period.
Administration of long-acting immune-modifying drugs within 90 days before enrollment or planned use at any time during the study period.
Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention administration, or planned administration during the study period. Administration of monoclonal antibodies specifically directed against the spike protein of SARS-CoV-2 virus, for treatment of COVID-19 disease is allowed.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the study intervention administration. For corticosteroids, this will mean prednisone equivalent ≥ 20 mg/day. Inhaled, topical and intraarticular steroids are allowed.
Previous enrolment in this study.
Other exclusions
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions within the 1-month post-dosing period.
History of abusive alcohol and/or drug consumption in the past 5 years.
Any study personnel or their immediate dependents, family, or household members.
Participants with extensive tattoos covering deltoid region on both arms that would preclude the assessment of local reactogenicity.
Leroux-Roels I, De Coster I, Borobia AM, Langley JM, Ochoa Mazarro D, Ruiz-Antoran B, Berre S, Germain S, Knauer C, Koch SD, Mann P, Mesia Vela D, Ovbude LJ, Pardo IA, Srivastava B, Moldt B, Nordgren M. Safety and immunogenicity of an investigational mRNA-lipid nanoparticle-based monovalent influenza vaccine: Results from a phase 1, randomized, dose-escalation study. Hum Vaccin Immunother. 2026 Dec;22(1):2631804. doi: 10.1080/21645515.2026.2631804. Epub 2026 Feb 17.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
IPD for this study will be made available via the Clinical Study Data Request site.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
As described in the protocol and analysis plan, all participants receiving either FDQ21A-NH or FDQ22A-NH are analyzed together as a pooled group throughout the study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Flu mRNA_Dose Level 1_Younger Adults (YA)
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
FG001
Flu mRNA_Dose Level 2 _YA
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jun 23, 2023
Sep 26, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Quadruple
Masking Description
Data were collected in an observer-blind manner: participants and site evaluators were blinded, while the sponsor and certain study personnel were aware of treatment assignments. For Dose Levels 1, 2, 5, and 6, data were collected in a single-blind manner-investigators were aware of the intervention, but participants were blinded.
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
Biological: GSK4382276A Dose level 6
Flu mRNA_Dose level 7_YA
Experimental
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
Biological: GSK4382276A Dose level 7
Flu mRNA_ Dose level 8_YA
Experimental
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
Biological: GSK4382276A Dose level 8
Flu mRNA_Dose level 9_YA
Experimental
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
Biological: GSK4382276A Dose level 9
Flu mRNA_Dose level 10_YA
Experimental
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
Biological: GSK4382276A Dose level 10
Pooled Control_YA
Active Comparator
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
Combination Product: FDQ21A-NH
Combination Product: FDQ22A-NH
Flu mRNA_Dose level 7_Older adults (OA)
Experimental
On Day 1, OA participants received Flu mRNA at Dose Level 7.
Biological: GSK4382276A Dose level 7
Control_OA
Active Comparator
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
Combination Product: FDQ21A-NH
Flu mRNA
GSK4382276A Dose level 2
Biological
Single dose of intervention administered at Day 1
Flu mRNA_Dose level 2 _YA
Flu mRNA
GSK4382276A Dose level 3
Biological
Single dose of intervention administered at Day 1
Flu mRNA_Dose level 3_YA
Flu mRNA
GSK4382276A Dose level 4
Biological
Single dose of intervention administered at Day 1
Flu mRNA_Dose level 4_YA
Flu mRNA
GSK4382276A Dose level 5
Biological
Single dose of intervention administered at Day 1
Flu mRNA_Dose level 5_YA
Flu mRNA
GSK4382276A Dose level 6
Biological
Single dose of intervention administered at Day 1
Flu mRNA_Dose level 6_YA
Flu mRNA
GSK4382276A Dose level 7
Biological
Single dose of intervention administered at Day 1
Flu mRNA_Dose level 7_Older adults (OA)
Flu mRNA_Dose level 7_YA
Flu mRNA
GSK4382276A Dose level 8
Biological
Single dose of intervention administered at Day 1
Flu mRNA_ Dose level 8_YA
Flu mRNA
GSK4382276A Dose level 9
Biological
Single dose of intervention administered at Day 1
Flu mRNA_Dose level 9_YA
Flu mRNA
GSK4382276A Dose level 10
Biological
Single dose of intervention administered at Day 1
Flu mRNA_Dose level 10_YA
Flu mRNA
FDQ21A-NH
Combination Product
Single dose of intervention administered at Day 1
Control_OA
Pooled Control_YA
FDQ22A-NH
Combination Product
Single dose of intervention administered at Day 1
Pooled Control_YA
The following events were considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs).
Day 1 to Day 183
Number of Participants Reporting Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 8 for Hematology, Clinical Chemistry, Coagulation and Urine Analysis
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
At Day 8 compared to baseline (Day 1)
Number of Participants Reporting Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 29 for Hematology,Clinical Chemistry, Coagulation and Urine Analysis
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
At Day 29 compared to baseline (Day 1)
Geometric Mean Titers (GMT) of Anti-vaccine Antibody Titers
At Day 1
GMT of Anti-vaccine Antibody Titers
At Day 22
Geometric Mean Increase (GMI) of Anti-vaccine Antibody Titers From Day 1 (Baseline) to Day 22
GMI is defined as the geometric mean of the ratios of the post-dose anti-vaccine antibody titers over the Day 1 anti-vaccine antibody titers.
From Day 1 to Day 22
Percentage of Participants With Anti-vaccine Antibody Seroconversion Rate (SCR)
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer < 1:10 and a post-dose anti-vaccine antibody titer ≥ 1:40 or a pre-dose anti-vaccine antibody titer ≥ 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer.
From Day 1 to Day 22
Percentage of Participants With Anti-vaccine Antibody Seroprotection Rate (SPR)
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer ≥ 1:40.
At Day 22
From Day 1 to Day 62
GMI of Anti-vaccine Antibody Titers From Day 1 (Baseline) to Day 183
GMI is defined as the geometric mean of the ratios of the post-dose anti-vaccine antibody titer over the Day 1 anti-vaccine antibody titer.
From Day 1 to Day 183
Percentage of Participants With Anti-vaccine Antibody SPR
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titers ≥ 1:40.
At Day 62 and Day 183
Ghent
9000
Belgium
GSK Investigational Site
Halifax
Nova Scotia
B3J 3G9
Canada
GSK Investigational Site
Sherbrooke
Quebec
J1L 0H8
Canada
GSK Investigational Site
Madrid
28006
Spain
GSK Investigational Site
Madrid
28046
Spain
GSK Investigational Site
Madrid
28222
Spain
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
FG002
Flu mRNA_Dose Level 3_YA
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
FG003
Flu mRNA_Dose Level 4_YA
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
FG004
Flu mRNA_Dose Level 5_YA
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
FG005
Flu mRNA_Dose Level 6_YA
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
FG006
Flu mRNA_Dose Level 7_YA
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
FG007
Flu mRNA_ Dose Level 8_YA
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
FG008
Flu mRNA_Dose Level 9_YA
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
FG009
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
FG010
Pooled Control_YA
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
FG011
Flu mRNA_Dose Level 7_Older Adults (OA)
On Day 1, OA participants received Flu mRNA at Dose Level 7.
FG012
Control_OA
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
FG00024 subjects
FG00124 subjects
FG00224 subjects
FG00324 subjects
FG00424 subjects
FG00524 subjects
FG00624 subjects
FG00724 subjects
FG00825 subjects
FG00924 subjects
FG01035 subjects
FG01132 subjects
FG01216 subjects
COMPLETED
FG00024 subjects
FG00124 subjects
FG00224 subjects
FG00324 subjects
FG00424 subjects
FG00524 subjects
FG00622 subjects
FG00724 subjects
FG00825 subjects
FG00923 subjects
FG01035 subjects
FG01132 subjects
FG01216 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Flu mRNA_Dose Level 1_Younger Adults (YA)
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
BG001
Flu mRNA_Dose Level 2 _YA
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
BG002
Flu mRNA_Dose Level 3_YA
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
BG003
Flu mRNA_Dose Level 4_YA
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
BG004
Flu mRNA_Dose Level 5_YA
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
BG005
Flu mRNA_Dose Level 6_YA
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
BG006
Flu mRNA_Dose Level 7_YA
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
BG007
Flu mRNA_ Dose Level 8_YA
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
BG008
Flu mRNA_Dose Level 9_YA
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
BG009
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
BG010
Pooled Control_YA
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
BG011
Flu mRNA_Dose Level 7_Older Adults (OA)
On Day 1, OA participants received Flu mRNA at Dose Level 7.
BG012
Control_OA
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
BG013
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00024
BG00124
BG00224
BG00324
BG00424
BG00524
BG00624
BG00724
BG00825
BG00924
BG01035
BG01132
BG01216
BG013324
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
The Age Continuous analysis is presented separately for YA and OA.
Mean
Standard Deviation
Years
Title
Denominators
Categories
YA
ParticipantsBG00024
ParticipantsBG00124
ParticipantsBG00224
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00024
ParticipantsBG00124
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Asian
ParticipantsBG00024
ParticipantsBG00124
ParticipantsBG002
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 Reporting Any Solicited Administration Site Events
Assessed solicited administration site events included pain, erythema/redness, swelling and Lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
The analysis was performed on the Exposed Set (ES), which included all participants who received a study intervention and for whom solicited administration site events data were available for the specified duration.
Posted
Count of Participants
Participants
Day 1 to Day 7
ID
Title
Description
OG000
Flu mRNA_Dose Level 1_Younger Adults (YA)
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
OG001
Flu mRNA_Dose Level 2 _YA
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
OG002
Flu mRNA_Dose Level 3_YA
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2
OG003
Flu mRNA_Dose Level 4_YA
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
OG004
Flu mRNA_Dose Level 5_YA
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
OG005
Flu mRNA_Dose Level 6_YA
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
OG006
Flu mRNA_Dose Level 7_YA
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
OG007
Flu mRNA_ Dose Level 8_YA
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
OG008
Flu mRNA_Dose Level 9_YA
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
OG009
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
OG010
Pooled Control_YA
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
OG011
Flu mRNA_Dose Level 7_Older Adults (OA)
On Day 1, OA participants received Flu mRNA at Dose Level 7.
OG012
Control_OA
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG003
Title
Denominators
Categories
Erythema
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events included fever, chills, headache, myalgia, arthralgia and fatigue. Any = occurrence of the symptom regardless of intensity grade.
The analysis was performed on the ES, which included all participants who received a study intervention and for whom solicited systemic events data were available for the specified duration.
Posted
Count of Participants
Participants
Day 1 to Day 7
ID
Title
Description
OG000
Flu mRNA_Dose Level 1_Younger Adults (YA)
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
OG001
Flu mRNA_Dose Level 2 _YA
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
OG002
Flu mRNA_Dose Level 3_YA
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
OG003
Flu mRNA_Dose Level 4_YA
Primary
Number of Participants Reporting Any Unsolicited Adverse Events (AEs)
An unsolicited AEs is an AEs that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs must have been communicated by a participant who has signed the informed consent or through his/her caregiver. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the symptom regardless of intensity grade or relation to study vaccination.
The analysis was performed on the ES, which included all participants who received a study intervention and for whom unsolicited AEs data were available for the specified duration.
Posted
Count of Participants
Participants
Day 1 to Day 28
ID
Title
Description
OG000
Flu mRNA_Dose Level 1_Younger Adults (YA)
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
OG001
Flu mRNA_Dose Level 2 _YA
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
OG002
Flu mRNA_Dose Level 3_YA
Primary
Number of Participants Reporting Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or resulted in abnormal pregnancy outcomes, or in other situations that were considered serious per medical or scientific judgment.
The analysis was performed on the ES, which included all participants who received a study intervention and for whom data were available for the specified duration.
Posted
Count of Participants
Participants
Day 1 to Day 183
ID
Title
Description
OG000
Flu mRNA_Dose Level 1_Younger Adults (YA)
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
OG001
Flu mRNA_Dose Level 2 _YA
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
OG002
Flu mRNA_Dose Level 3_YA
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
Primary
Number of Participants Reporting AEs of Special Interest (AESIs)
The following events were considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs).
The analysis was performed on the ES, which included all participants who received a study intervention and for whom data were available for the specified duration.
Posted
Count of Participants
Participants
Day 1 to Day 183
ID
Title
Description
OG000
Flu mRNA_Dose Level 1_Younger Adults (YA)
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
OG001
Flu mRNA_Dose Level 2 _YA
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
OG002
Flu mRNA_Dose Level 3_YA
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
OG003
Flu mRNA_Dose Level 4_YA
Primary
Number of Participants Reporting Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 8 for Hematology, Clinical Chemistry, Coagulation and Urine Analysis
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
The analysis was performed on the ES, which included all participants who received a study intervention and for whom data were available for the specified duration.
Posted
Count of Participants
Participants
At Day 8 compared to baseline (Day 1)
ID
Title
Description
OG000
Flu mRNA_Dose Level 1_Younger Adults (YA)
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
OG001
Flu mRNA_Dose Level 2 _YA
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
OG002
Flu mRNA_Dose Level 3_YA
Primary
Number of Participants Reporting Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 29 for Hematology,Clinical Chemistry, Coagulation and Urine Analysis
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
The analysis was performed on the ES, which included all participants who received a study intervention and for whom data were available for the specified duration.
Posted
Count of Participants
Participants
At Day 29 compared to baseline (Day 1)
ID
Title
Description
OG000
Flu mRNA_Dose Level 1_Younger Adults (YA)
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
OG001
Flu mRNA_Dose Level 2 _YA
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
OG002
Flu mRNA_Dose Level 3_YA
Primary
Geometric Mean Titers (GMT) of Anti-vaccine Antibody Titers
The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention per protocol, had recorded anti-vaccine antibody titers immunogenicity results pre- and post-dose, without intercurrent conditions, did not use prohibited medications or vaccinations before Day 22, and for whom data were available for the specified analysis at the specified timepoints. Blood sample results that deviated from the analysis criteria were excluded.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 1
ID
Title
Description
OG000
Flu mRNA_Dose Level 1_Younger Adults (YA)
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
OG001
Flu mRNA_Dose Level 2 _YA
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
OG002
Flu mRNA_Dose Level 3_YA
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
OG003
Primary
GMT of Anti-vaccine Antibody Titers
The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention per protocol, had recorded anti-vaccine antibody titers immunogenicity results pre- and post-dose, without intercurrent conditions, did not use prohibited medications or vaccinations before Day 22, and for whom data were available for the specified analysis at the specified timepoints. Blood sample results that deviated from the analysis criteria were excluded.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 22
ID
Title
Description
OG000
Flu mRNA_Dose Level 1_Younger Adults (YA)
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
OG001
Flu mRNA_Dose Level 2 _YA
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
OG002
Flu mRNA_Dose Level 3_YA
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
OG003
Primary
Geometric Mean Increase (GMI) of Anti-vaccine Antibody Titers From Day 1 (Baseline) to Day 22
GMI is defined as the geometric mean of the ratios of the post-dose anti-vaccine antibody titers over the Day 1 anti-vaccine antibody titers.
The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention per protocol, had recorded anti-vaccine antibody titers immunogenicity results pre- and post-dose, without intercurrent conditions, did not use prohibited medications or vaccinations before Day 22, and for whom data were available for the specified analysis at the specified timepoints. Blood sample results that deviated from the analysis criteria were excluded.
Posted
Geometric Mean
95% Confidence Interval
Ratio
From Day 1 to Day 22
ID
Title
Description
OG000
Flu mRNA_Dose Level 1_Younger Adults (YA)
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
OG001
Flu mRNA_Dose Level 2 _YA
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
OG002
Flu mRNA_Dose Level 3_YA
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
Primary
Percentage of Participants With Anti-vaccine Antibody Seroconversion Rate (SCR)
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer < 1:10 and a post-dose anti-vaccine antibody titer ≥ 1:40 or a pre-dose anti-vaccine antibody titer ≥ 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer.
The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention per protocol, had recorded anti-vaccine antibody titers immunogenicity results pre- and post-dose, without intercurrent conditions, did not use prohibited medications or vaccinations before Day 22, and for whom data were available for the specified analysis at the specified timepoints. Blood sample results that deviated from the analysis criteria were excluded.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 to Day 22
ID
Title
Description
OG000
Flu mRNA_Dose Level 1_Younger Adults (YA)
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
OG001
Flu mRNA_Dose Level 2 _YA
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
OG002
Primary
Percentage of Participants With Anti-vaccine Antibody Seroprotection Rate (SPR)
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer ≥ 1:40.
The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention per protocol, had recorded anti-vaccine antibody titers immunogenicity results pre- and post-dose, without intercurrent conditions, did not use prohibited medications or vaccinations before Day 22, and for whom data were available for the specified analysis at the specified timepoints. Blood sample results that deviated from the analysis criteria were excluded.
Posted
Number
95% Confidence Interval
Percentage of participants
At Day 22
ID
Title
Description
OG000
Flu mRNA_Dose Level 1_Younger Adults (YA)
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
OG001
Flu mRNA_Dose Level 2 _YA
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
OG002
Flu mRNA_Dose Level 3_YA
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
Secondary
GMT of Anti-vaccine Antibody Titers
The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention per protocol, had recorded anti-HI immunogenicity results pre- and post-dose, without intercurrent conditions, did not use prohibited medications or vaccinations before Day 22, and for whom data were available for the specified analysis at the specified timepoints. Blood sample results that deviated from the analysis criteria were excluded.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 62 and Day 183
ID
Title
Description
OG000
Flu mRNA_Dose Level 1_Younger Adults (YA)
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
OG001
Flu mRNA_Dose Level 2 _YA
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
OG002
Flu mRNA_Dose Level 3_YA
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
OG003
Flu mRNA_Dose Level 4_YA
Secondary
GMI of Anti-vaccine Antibody Titers From Day 1 (Baseline) to Day 62
GMI is defined as the geometric mean of the ratios of the post-dose anti-vaccine antibody titer over the Day 1 anti-vaccine antibody titer.
The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention per protocol, had recorded anti-vaccine antibody titers immunogenicity results pre- and post-dose, without intercurrent conditions, did not use prohibited medications or vaccinations before Day 22, and for whom data were available for the specified analysis at the specified timepoints. Blood sample results that deviated from the analysis criteria were excluded.
Posted
Geometric Mean
95% Confidence Interval
Ratio
From Day 1 to Day 62
ID
Title
Description
OG000
Flu mRNA_Dose Level 1_Younger Adults (YA)
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
OG001
Flu mRNA_Dose Level 2 _YA
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
OG002
Flu mRNA_Dose Level 3_YA
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
Secondary
GMI of Anti-vaccine Antibody Titers From Day 1 (Baseline) to Day 183
GMI is defined as the geometric mean of the ratios of the post-dose anti-vaccine antibody titer over the Day 1 anti-vaccine antibody titer.
The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention per protocol, had recorded anti-vaccine antibody titers immunogenicity results pre- and post-dose, without intercurrent conditions, did not use prohibited medications or vaccinations before Day 22, and for whom data were available for the specified analysis at the specified timepoints. Blood sample results that deviated from the analysis criteria were excluded.
Posted
Geometric Mean
95% Confidence Interval
Ratio
From Day 1 to Day 183
ID
Title
Description
OG000
Flu mRNA_Dose Level 1_Younger Adults (YA)
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
OG001
Flu mRNA_Dose Level 2 _YA
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
OG002
Flu mRNA_Dose Level 3_YA
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
Secondary
Percentage of Participants With Anti-vaccine Antibody SPR
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titers ≥ 1:40.
The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention per protocol, had recorded anti-HI immunogenicity results pre- and post-dose, without intercurrent conditions, did not use prohibited medications or vaccinations before Day 22, and for whom data were available for the specified analysis at the specified timepoints. Blood sample results that deviated from the analysis criteria were excluded.
Posted
Number
95% Confidence Interval
Percentage of participants
At Day 62 and Day 183
ID
Title
Description
OG000
Flu mRNA_Dose Level 1_Younger Adults (YA)
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
OG001
Flu mRNA_Dose Level 2 _YA
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
OG002
Flu mRNA_Dose Level 3_YA
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
Time Frame
Solicited AEs: during the 7-day follow-up period after vaccination. Unsolicited AEs: during the 28-day follow-up period after vaccination. All-cause mortality, SAEs and AESIs: from first vaccination (Day 1) up to study end (Day 183)
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
Flu mRNA_Dose Level 1_Younger Adults (YA)
On Day 1, YA adult participants received Flu mRNA at Dose Level 1, the lowest concentration evaluated in the study.
0
24
1
24
17
24
EG001
Flu mRNA_Dose Level 2 _YA
On Day 1, YA participants received Flu mRNA at Dose Level 2, which corresponds to a higher concentration than Dose Level 1.
0
24
0
24
20
24
EG002
Flu mRNA_Dose Level 3_YA
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
0
24
0
24
21
24
EG003
Flu mRNA_Dose Level 4_YA
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
0
24
0
24
19
24
EG004
Flu mRNA_Dose Level 5_YA
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
0
24
2
24
22
24
EG005
Flu mRNA_Dose Level 6_YA
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
0
24
0
24
24
24
EG006
Flu mRNA_Dose Level 7_YA
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
0
24
0
24
23
24
EG007
Flu mRNA_ Dose Level 8_YA
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
0
24
0
24
23
24
EG008
Flu mRNA_Dose Level 9_YA
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
0
25
0
25
25
25
EG009
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
0
24
0
24
24
24
EG010
Pooled Control_YA
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
0
35
1
35
32
35
EG011
Flu mRNA_Dose Level 7_Older Adults (OA)
On Day 1, OA participants received Flu mRNA at Dose Level 7.
0
32
1
32
24
32
EG012
Control_OA
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
0
16
0
16
12
16
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal infection
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG0030 events0 affected24 at risk
EG0040 events0 affected24 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected24 at risk
EG0080 events0 affected25 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected35 at risk
EG0111 events1 affected32 at risk
EG0120 events0 affected16 at risk
Craniofacial fracture
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Poisoning deliberate
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Ovarian germ cell teratoma benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Depression
Psychiatric disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenopathy
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected24 at risk
EG0024 events4 affected24 at risk
EG0033 events3 affected24 at risk
EG0045 events5 affected24 at risk
EG0054 events4 affected24 at risk
EG0067 events7 affected24 at risk
EG0079 events9 affected24 at risk
EG0089 events9 affected25 at risk
EG00912 events12 affected24 at risk
EG01010 events10 affected35 at risk
EG0110 events0 affected32 at risk
EG0120 events0 affected16 at risk
Palpitations
Cardiac disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Ear pain
Ear and labyrinth disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Blepharospasm
Eye disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Chalazion
Eye disorders
27.0
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Dry eye
Eye disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Lacrimation increased
Eye disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Abdominal pain
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0013 events3 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Diarrhoea
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0012 events2 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Dyspepsia
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Nausea
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Toothache
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Vomiting
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Administration site acne
General disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Administration site erythema
General disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Administration site pain
General disorders
27.0
Systematic Assessment
EG0005 events5 affected24 at risk
EG0016 events6 affected24 at risk
EG0028 events8 affected24 at risk
EG003
Administration site pruritus
General disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Administration site swelling
General disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Administration site warmth
General disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Asthenia
General disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Chest pain
General disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Chills
General disorders
27.0
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Fatigue
General disorders
27.0
Systematic Assessment
EG0009 events8 affected24 at risk
EG0018 events8 affected24 at risk
EG00212 events12 affected24 at risk
EG003
Feeling hot
General disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Hangover
General disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Influenza like illness
General disorders
27.0
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Injection site bruising
General disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Injection site haemorrhage
General disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Injection site pruritus
General disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Injection site reaction
General disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Malaise
General disorders
27.0
Systematic Assessment
EG0002 events2 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Pyrexia
General disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Swelling
General disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Temperature regulation disorder
General disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Vaccination site pain
General disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Vessel puncture site erythema
General disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
COVID-19
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Chlamydial infection
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Gastroenteritis
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Herpes zoster
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Nasopharyngitis
Infections and infestations
27.0
Systematic Assessment
EG0003 events3 affected24 at risk
EG0010 events0 affected24 at risk
EG0022 events1 affected24 at risk
EG003
Omphalitis
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Oral herpes
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Otitis media
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Pharyngotonsillitis
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Respiratory tract infection
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Rhinitis
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Sinusitis
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Tonsillitis
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0012 events2 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Tracheitis
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Upper respiratory tract infection
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Urinary tract infection
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Vaginal infection
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Burns first degree
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Cartilage injury
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Contusion
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Iliotibial band syndrome
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Immunisation reaction
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Alanine aminotransferase increased
Investigations
27.0
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Aspartate aminotransferase increased
Investigations
27.0
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Blood urea increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
C-reactive protein increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Neutrophil count increased
Investigations
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0002 events2 affected24 at risk
EG0012 events2 affected24 at risk
EG0024 events3 affected24 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Joint hyperextension
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0003 events3 affected24 at risk
EG0013 events3 affected24 at risk
EG0024 events4 affected24 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Anogenital warts
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Fibroadenoma of breast
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Dizziness
Nervous system disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Headache
Nervous system disorders
27.0
Systematic Assessment
EG00012 events11 affected24 at risk
EG00110 events8 affected24 at risk
EG00210 events8 affected24 at risk
EG003
Hypoaesthesia
Nervous system disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Paraesthesia
Nervous system disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Taste disorder
Nervous system disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Depressed mood
Psychiatric disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Breast pain
Reproductive system and breast disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Menstruation delayed
Reproductive system and breast disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Increased upper airway secretion
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0001 events1 affected24 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0002 events2 affected24 at risk
EG0012 events2 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Respiratory symptom
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0001 events1 affected24 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Hand dermatitis
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Skin discomfort
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Haematoma
Vascular disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Hot flush
Vascular disorders
27.0
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
OG004
Flu mRNA_Dose Level 5_YA
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
OG005
Flu mRNA_Dose Level 6_YA
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
OG006
Flu mRNA_Dose Level 7_YA
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
OG007
Flu mRNA_ Dose Level 8_YA
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
OG008
Flu mRNA_Dose Level 9_YA
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
OG009
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
OG010
Pooled Control_YA
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
OG011
Flu mRNA_Dose Level 7_Older Adults (OA)
On Day 1, OA participants received Flu mRNA at Dose Level 7.
OG012
Control_OA
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00424
OG00524
OG00624
OG00724
OG00825
OG00924
OG01035
OG01132
OG01216
Title
Denominators
Categories
Arthralgia
Title
Measurements
OG0001
OG0012
OG0023
OG0033
OG0043
OG0053
OG0064
OG0077
OG0086
OG00915
OG0104
OG0112
OG0122
Chills
Title
Measurements
OG0001
OG0010
OG0020
OG003
Fatigue
Title
Measurements
OG0008
OG0018
OG00212
OG003
Headache
Title
Measurements
OG00011
OG0016
OG0024
OG003
Myalgia
Title
Measurements
OG0002
OG0013
OG0024
OG003
Fever
Title
Measurements
OG0000
OG0010
OG0021
OG003
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
OG003
Flu mRNA_Dose Level 4_YA
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
OG004
Flu mRNA_Dose Level 5_YA
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
OG005
Flu mRNA_Dose Level 6_YA
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
OG006
Flu mRNA_Dose Level 7_YA
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
OG007
Flu mRNA_ Dose Level 8_YA
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
OG008
Flu mRNA_Dose Level 9_YA
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
OG009
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
OG010
Pooled Control_YA
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
OG011
Flu mRNA_Dose Level 7_Older Adults (OA)
On Day 1, OA participants received Flu mRNA at Dose Level 7.
OG012
Control_OA
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00424
OG00524
OG00624
OG00724
OG00825
OG00924
OG01035
OG01132
OG01216
Title
Denominators
Categories
Title
Measurements
OG00013
OG00113
OG00214
OG00317
OG00413
OG00516
OG00612
OG00716
OG00815
OG00913
OG01024
OG01114
OG0128
OG003
Flu mRNA_Dose Level 4_YA
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
OG004
Flu mRNA_Dose Level 5_YA
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
OG005
Flu mRNA_Dose Level 6_YA
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
OG006
Flu mRNA_Dose Level 7_YA
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
OG007
Flu mRNA_ Dose Level 8_YA
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
OG008
Flu mRNA_Dose Level 9_YA
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
OG009
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study
OG010
Pooled Control_YA
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
OG011
Flu mRNA_Dose Level 7_Older Adults (OA)
On Day 1, OA participants received Flu mRNA at Dose Level 7.
OG012
Control_OA
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00424
OG00524
OG00624
OG00724
OG00825
OG00924
OG01035
OG01132
OG01216
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0042
OG0050
OG0060
OG0070
OG0080
OG0090
OG0101
OG0111
OG0120
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
OG004
Flu mRNA_Dose Level 5_YA
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
OG005
Flu mRNA_Dose Level 6_YA
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
OG006
Flu mRNA_Dose Level 7_YA
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
OG007
Flu mRNA_ Dose Level 8_YA
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
OG008
Flu mRNA_Dose Level 9_YA
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
OG009
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
OG010
Pooled Control_YA
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
OG011
Flu mRNA_Dose Level 7_Older Adults (OA)
On Day 1, OA participants received Flu mRNA at Dose Level 7.
OG012
Control_OA
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00424
OG00524
OG00624
OG00724
OG00825
OG00924
OG01035
OG01132
OG01216
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
OG003
Flu mRNA_Dose Level 4_YA
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
OG004
Flu mRNA_Dose Level 5_YA
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
OG005
Flu mRNA_Dose Level 6_YA
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
OG006
Flu mRNA_Dose Level 7_YA
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
OG007
Flu mRNA_ Dose Level 8_YA
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
OG008
Flu mRNA_Dose Level 9_YA
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
OG009
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
OG010
Pooled Control_YA
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
OG011
Flu mRNA_Dose Level 7_Older Adults (OA)
On Day 1, OA participants received Flu mRNA at Dose Level 7.
OG012
Control_OA
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00424
OG00524
OG00624
OG00724
OG00825
OG00924
OG01035
OG01132
OG01216
Title
Denominators
Categories
Abnormal non-significant to clinically significant
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0062
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
Normal or missing to clinically significant
Title
Measurements
OG0000
OG0012
OG0020
OG003
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
OG003
Flu mRNA_Dose Level 4_YA
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
OG004
Flu mRNA_Dose Level 5_YA
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
OG005
Flu mRNA_Dose Level 6_YA
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
OG006
Flu mRNA_Dose Level 7_YA
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
OG007
Flu mRNA_ Dose Level 8_YA
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
OG008
Flu mRNA_Dose Level 9_YA
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
OG009
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
OG010
Pooled Control_YA
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
OG011
Flu mRNA_Dose Level 7_Older Adults (OA)
On Day 1, OA participants received Flu mRNA at Dose Level 7.
OG012
Control_OA
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00424
OG00524
OG00624
OG00724
OG00825
OG00924
OG01035
OG01132
OG01216
Title
Denominators
Categories
Abnormal non-significant to clinically significant
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
OG0101
OG0110
OG0122
Normal or missing to clinically significant
Title
Measurements
OG0003
OG0010
OG0020
OG003
Flu mRNA_Dose Level 4_YA
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
OG004
Flu mRNA_Dose Level 5_YA
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
OG005
Flu mRNA_Dose Level 6_YA
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
OG006
Flu mRNA_Dose Level 7_YA
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
OG007
Flu mRNA_ Dose Level 8_YA
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
OG008
Flu mRNA_Dose Level 9_YA
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
OG009
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
OG010
Pooled Control_YA
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
OG011
Flu mRNA_Dose Level 7_Older Adults (OA)
On Day 1, OA participants received Flu mRNA at Dose Level 7.
OG012
Control_OA
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
Units
Counts
Participants
OG00023
OG00122
OG00223
OG00324
OG00424
OG00524
OG00623
OG00723
OG00824
OG00924
OG01034
OG01129
OG01216
Title
Denominators
Categories
Title
Measurements
OG00029.59(16.05 to 54.56)
OG00153.97(28.15 to 103.48)
OG00231.43(17.67 to 55.91)
OG00328.67(15.56 to 52.82)
OG00416.33(9.58 to 27.84)
OG00516.33(9.82 to 27.16)
OG00643.78(22.19 to 86.38)
OG00721.23(12.15 to 37.11)
OG00841.78(22.90 to 76.26)
OG00954.14(31.83 to 92.06)
OG01030.07(17.46 to 51.78)
OG01138.65(25.05 to 59.63)
OG01240.82(19.90 to 83.75)
Flu mRNA_Dose Level 4_YA
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
OG004
Flu mRNA_Dose Level 5_YA
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
OG005
Flu mRNA_Dose Level 6_YA
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
OG006
Flu mRNA_Dose Level 7_YA
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
OG007
Flu mRNA_ Dose Level 8_YA
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
OG008
Flu mRNA_Dose Level 9_YA
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
OG009
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
OG010
Pooled Control_YA
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
OG011
Flu mRNA_Dose Level 7_Older Adults (OA)
On Day 1, OA participants received Flu mRNA at Dose Level 7.
OG012
Control_OA
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
Units
Counts
Participants
OG00023
OG00122
OG00223
OG00323
OG00423
OG00524
OG00623
OG00723
OG00824
OG00924
OG01032
OG01129
OG01216
Title
Denominators
Categories
Title
Measurements
OG000269.00(120.50 to 600.47)
OG001314.88(139.83 to 709.07)
OG002420.90(191.00 to 927.55)
OG003436.90(198.46 to 961.79)
OG004509.49(228.62 to 1135.46)
OG005574.09(258.11 to 1276.91)
OG0061144.59(520.12 to 2518.84)
OG007655.57(308.11 to 1394.83)
OG0081124.85(568.42 to 2226.00)
OG009923.79(427.53 to 1996.07)
OG010313.07(151.79 to 645.71)
OG011571.29(384.74 to 848.30)
OG012245.66(159.33 to 378.76)
OG003
Flu mRNA_Dose Level 4_YA
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
OG004
Flu mRNA_Dose Level 5_YA
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
OG005
Flu mRNA_Dose Level 6_YA
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
OG006
Flu mRNA_Dose Level 7_YA
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
OG007
Flu mRNA_ Dose Level 8_YA
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
OG008
Flu mRNA_Dose Level 9_YA
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
OG009
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
OG010
Pooled Control_YA
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
OG011
Flu mRNA_Dose Level 7_Older Adults (OA)
On Day 1, OA participants received Flu mRNA at Dose Level 7.
OG012
Control_OA
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
Units
Counts
Participants
OG00023
OG00122
OG00223
OG00323
OG00423
OG00524
OG00623
OG00723
OG00824
OG00924
OG01032
OG01129
OG01216
Title
Denominators
Categories
Title
Measurements
OG0008.62(3.86 to 19.24)
OG00110.09(4.48 to 22.72)
OG00213.49(6.12 to 29.73)
OG00314.00(6.36 to 30.82)
OG00416.33(7.33 to 36.39)
OG00518.40(8.27 to 40.92)
OG00636.68(16.67 to 80.72)
OG00721.01(9.87 to 44.70)
OG00836.05(18.22 to 71.34)
OG00929.61(13.70 to 63.97)
OG01010.03(4.86 to 20.69)
OG01114.50(9.76 to 21.53)
OG0126.23(4.04 to 9.61)
Flu mRNA_Dose Level 3_YA
On Day 1, YA participants received Flu mRNA at Dose Level 3, which corresponds to a higher concentration than Dose Level 2.
OG003
Flu mRNA_Dose Level 4_YA
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
OG004
Flu mRNA_Dose Level 5_YA
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
OG005
Flu mRNA_Dose Level 6_YA
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
OG006
Flu mRNA_Dose Level 7_YA
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
OG007
Flu mRNA_ Dose Level 8_YA
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
OG008
Flu mRNA_Dose Level 9_YA
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
OG009
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
OG010
Pooled Control_YA
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
OG011
Flu mRNA_Dose Level 7_Older Adults (OA)
On Day 1, OA participants received Flu mRNA at Dose Level 7.
OG012
Control_OA
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
Units
Counts
Participants
OG00023
OG00122
OG00223
OG00323
OG00423
OG00524
OG00623
OG00723
OG00824
OG00924
OG01032
OG01129
OG01216
Title
Denominators
Categories
Title
Measurements
OG00047.8(26.8 to 69.4)
OG00150.0(28.2 to 71.8)
OG00282.6(61.2 to 95.0)
OG00378.3(56.3 to 92.5)
OG00495.7(78.1 to 99.9)
OG00595.8(78.9 to 99.9)
OG00687.0(66.4 to 97.2)
OG00795.7(78.1 to 99.9)
OG00895.8(78.9 to 99.9)
OG00995.8(78.9 to 99.9)
OG01059.4(40.6 to 76.3)
OG01189.7(72.6 to 97.8)
OG01256.3(29.9 to 80.2)
OG003
Flu mRNA_Dose Level 4_YA
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
OG004
Flu mRNA_Dose Level 5_YA
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
OG005
Flu mRNA_Dose Level 6_YA
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
OG006
Flu mRNA_Dose Level 7_YA
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
OG007
Flu mRNA_ Dose Level 8_YA
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
OG008
Flu mRNA_Dose Level 9_YA
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
OG009
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study.
OG010
Pooled Control_YA
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
OG011
Flu mRNA_Dose Level 7_Older Adults (OA)
On Day 1, OA participants received Flu mRNA at Dose Level 7.
OG012
Control_OA
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
Units
Counts
Participants
OG00023
OG00122
OG00223
OG00323
OG00423
OG00524
OG00623
OG00723
OG00824
OG00924
OG01032
OG01129
OG01216
Title
Denominators
Categories
Title
Measurements
OG00095.7(78.1 to 99.9)
OG001100(84.6 to 100)
OG002100(85.2 to 100)
OG003100(85.2 to 100)
OG004100(85.2 to 100)
OG005100(85.8 to 100)
OG006100(85.2 to 100)
OG007100(85.2 to 100)
OG008100(85.8 to 100)
OG009100(85.8 to 100)
OG010100(89.1 to 100)
OG01196.6(82.2 to 99.9)
OG01293.8(69.8 to 99.8)
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
OG004
Flu mRNA_Dose Level 5_YA
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
OG005
Flu mRNA_Dose Level 6_YA
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
OG006
Flu mRNA_Dose Level 7_YA
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
OG007
Flu mRNA_ Dose Level 8_YA
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
OG008
Flu mRNA_Dose Level 9_YA
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
OG009
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study. No blood sampling were performed at Day 62 and Day 183 for the dose level 10.
OG010
Pooled Control_YA
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
OG011
Flu mRNA_Dose Level 7_Older Adults (OA)
On Day 1, OA participants received Flu mRNA at Dose Level 7.
OG012
Control_OA
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
Units
Counts
Participants
OG00021
OG00119
OG00223
OG00321
OG00424
OG00524
OG00614
OG00717
OG00820
OG0090
OG01023
OG01115
OG01210
Title
Denominators
Categories
Post-dosing at Day 62
ParticipantsOG00021
ParticipantsOG00119
ParticipantsOG00223
ParticipantsOG00321
ParticipantsOG00424
ParticipantsOG00524
ParticipantsOG00614
ParticipantsOG00717
ParticipantsOG00820
ParticipantsOG0090
ParticipantsOG01023
ParticipantsOG01115
ParticipantsOG01210
Title
Measurements
OG000180.49(81.00 to 402.16)
OG001165.29(73.19 to 373.31)
OG002253.76(116.06 to 554.84)
OG003
Post-dosing at Day 183
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG00216
ParticipantsOG00317
OG003
Flu mRNA_Dose Level 4_YA
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
OG004
Flu mRNA_Dose Level 5_YA
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
OG005
Flu mRNA_Dose Level 6_YA
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
OG006
Flu mRNA_Dose Level 7_YA
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
OG007
Flu mRNA_ Dose Level 8_YA
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
OG008
Flu mRNA_Dose Level 9_YA
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
OG009
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study. No blood sampling were performed at Day 62 and Day 183 for the dose level 10.
OG010
Pooled Control_YA
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
OG011
Flu mRNA_Dose Level 7_Older Adults (OA)
On Day 1, OA participants received Flu mRNA at Dose Level 7.
OG012
Control_OA
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
Units
Counts
Participants
OG00021
OG00119
OG00223
OG00321
OG00424
OG00524
OG00614
OG00717
OG00820
OG0090
OG01023
OG01115
OG01210
Title
Denominators
Categories
Title
Measurements
OG0006.87(3.08 to 15.32)
OG0016.29(2.79 to 14.22)
OG0029.66(4.42 to 21.13)
OG00312.40(5.63 to 27.31)
OG00412.00(5.47 to 26.36)
OG00512.01(5.45 to 26.48)
OG00622.31(9.70 to 51.31)
OG00712.98(6.19 to 27.19)
OG00826.78(13.85 to 51.79)
OG0108.52(4.06 to 17.89)
OG0118.05(4.85 to 13.34)
OG0125.11(2.87 to 9.10)
OG003
Flu mRNA_Dose Level 4_YA
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
OG004
Flu mRNA_Dose Level 5_YA
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
OG005
Flu mRNA_Dose Level 6_YA
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
OG006
Flu mRNA_Dose Level 7_YA
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
OG007
Flu mRNA_ Dose Level 8_YA
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
OG008
Flu mRNA_Dose Level 9_YA
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
OG009
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study. No blood sampling were performed at Day 62 and Day 183 for the dose level 10.
OG010
Pooled Control_YA
On Day 1, YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
OG011
Flu mRNA_Dose Level 7_Older Adults (OA)
On Day 1, OA participants received Flu mRNA at Dose Level 7.
OG012
Control_OA
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.
Units
Counts
Participants
OG00017
OG00117
OG00216
OG00317
OG00423
OG00524
OG0068
OG00715
OG00820
OG0090
OG01019
OG01112
OG0126
Title
Denominators
Categories
Title
Measurements
OG0006.35(2.71 to 14.90)
OG0015.43(2.30 to 12.82)
OG0028.33(3.56 to 19.51)
OG0039.12(3.95 to 21.06)
OG0047.86(3.46 to 17.87)
OG0059.39(4.14 to 21.32)
OG0069.19(3.52 to 23.98)
OG0079.49(4.34 to 20.72)
OG00813.98(7.02 to 27.83)
OG0108.73(4.03 to 18.90)
OG0113.73(1.95 to 7.12)
OG0122.88(1.13 to 7.33)
OG003
Flu mRNA_Dose Level 4_YA
On Day 1, YA participants received Flu mRNA at Dose Level 4, which corresponds to a higher concentration than Dose Level 3.
OG004
Flu mRNA_Dose Level 5_YA
On Day 1, YA participants received Flu mRNA at Dose Level 5, which corresponds to a higher concentration than Dose Level 4.
OG005
Flu mRNA_Dose Level 6_YA
On Day 1, YA participants received Flu mRNA at Dose Level 6, which corresponds to a higher concentration than Dose Level 5.
OG006
Flu mRNA_Dose Level 7_YA
On Day 1, YA participants received Flu mRNA at Dose Level 7, which corresponds to a higher concentration than Dose Level 6.
OG007
Flu mRNA_ Dose Level 8_YA
On Day 1, YA participants received Flu mRNA at Dose Level 8, which corresponds to a higher concentration than Dose Level 7.
OG008
Flu mRNA_Dose Level 9_YA
On Day 1, YA participants received Flu mRNA at Dose Level 9, which corresponds to a higher concentration than Dose Level 8.
OG009
Flu mRNA_Dose Level 10_YA
On Day 1, YA participants received Flu mRNA at Dose Level 10, the highest concentration evaluated in the study. No blood sampling were performed at Day 62 and Day 183 for the dose level 10.
OG010
Pooled Control_YA
On Day 1 YA participants received a single dose of FDQ21A - NH or FDQ22A -NH administered as a control and were analyzed together as pooled group throughout the study.
OG011
Flu mRNA_Dose Level 7_Older Adults (OA)
On Day 1, OA participants received Flu mRNA at Dose Level 7.
OG012
Control_OA
On Day 1, OA participants received a single dose of FDQ21A-NH administered at as a control.