A Study About Modified RNA Vaccines Against Influenza in... | NCT06436703 | Trialant
NCT06436703
Sponsor
Pfizer
Status
Completed
Last Update Posted
Jun 12, 2026Actual
Enrollment
1,202Actual
Phase
Phase 1Phase 2
Conditions
Influenza, Human
Interventions
Influenza ModRNA Vaccine
Quadrivalent Influenza Vaccine (QIV)
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT06436703
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C4781013
Secondary IDs
ID
Type
Description
Link
NCT06436703
Registry Identifier
ClinicalTrials.gov
Brief Title
A Study About Modified RNA Vaccines Against Influenza in Healthy Adults
Official Title
A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINES AGAINST INFLUENZA IN HEALTHY ADULTS
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jun 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
May 23, 2024Actual
Primary Completion Date
Feb 5, 2025Actual
Completion Date
Feb 5, 2025Actual
First Submitted Date
May 24, 2024
First Submission Date that Met QC Criteria
May 30, 2024
First Posted Date
May 31, 2024Actual
Results Waived
Not provided
Results First Submitted Date
Jan 15, 2026
Results First Submitted that Met QC Criteria
Jun 9, 2026
Results First Posted Date
Jun 12, 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
Jun 9, 2026
Last Update Posted Date
Jun 12, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to learn if modified RNA (modRNA) vaccines for the prevention of influenza are:
safe; and
how these vaccines produce an immune response in generally healthy adults. Immune response is the way the body protects itself against things it sees as harmful or foreign.
RNA (also called ribonucleic acid) is one of two types of nucleic acid made by cells. RNA contains information that has been copied from DNA (the other type of nucleic acid). Cells make several different forms of RNA, and each form has a specific job in the cell. Many forms of RNA have functions related to making proteins. RNA is also the genetic material of some viruses instead of DNA. RNA can be made in the laboratory and used in research studies. Also called ribonucleic acid.
Influenza is term used for flu illness. It is an infection caused by a virus that affects your mouth, nose, and throat.
The study is seeking for participants who:
are at least 18 years of age
have not received an influenza vaccine within the last 6 months
are generally healthy
This study will be divided into three sub-studies: Substudy A (SSA), Substudy B (SSB), and Substudy C (SSC).
All participants, regardless of sub-study, will receive 1 dose of either of the following vaccines as an injection into their arm:
1 of the modRNA influenza vaccines that is being studied; or
an approved influenza vaccine approved for use in their respective age group.
Participants will be involved in this study for about 6 months. During this time, participants will have at least 3 clinic visits.
Detailed Description
Not provided
Conditions Module
Conditions
Influenza, Human
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,202Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
SSA: Influenza ModRNA Vaccine 2A
Experimental
- Single Dose on Day 1
Biological: Influenza ModRNA Vaccine
SSA: Influenza ModRNA Vaccine 3A
Experimental
- Single Dose on Day 1
Biological: Influenza ModRNA Vaccine
SSA: Influenza ModRNA Vaccine 4A
Experimental
- Single Dose on Day 1
Biological: Influenza ModRNA Vaccine
SSA: Influenza ModRNA Vaccine 5A
Experimental
- Single dose on Day 1
Biological: Influenza ModRNA Vaccine
SSA: QIV1
Active Comparator
- Single dose on Day 1
Biological: Quadrivalent Influenza Vaccine (QIV)
SSB: Influenza ModRNA Vaccine 3B
Experimental
- Single Dose on Day 1
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Influenza ModRNA Vaccine
Biological
Intramuscular injection
SSA: Influenza ModRNA Vaccine 2A
SSA: Influenza ModRNA Vaccine 3A
SSA: Influenza ModRNA Vaccine 4A
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
SSA: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the electronic dairy (e-diary) or by investigators in case report form (CRF) after vaccination. All local reactions were graded based on center for biologics evaluation and research (CBER) toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSB: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. All local reactions were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSC: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. All local reactions were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSA: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
Secondary Outcomes
Measure
Description
Time Frame
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at Baseline and 4 Weeks After Vaccination
GMTs and the corresponding 2-sided 95% confidence intervals (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria
Applies to all 3 substudies:
participants ≥18 years of age.
generally healthy participants.
Substudy C ONLY:
- receipt of licensed influenza vaccination for the 2023-2024 flu season at least 6 months ago.
Key Exclusion Criteria
All 3 substudies:
diagnosis of influenza (by clinical testing) in the last 6 months.
immunocompromised individuals with known or suspected immunodeficiency
receipt of any investigational or licensed influenza vaccines within 6 months.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
AMR Clinical
Mobile
Alabama
36608
United States
Headlands Research - Scottsdale
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Dose levels for nucleoside-modified ribonucleic acid (modRNA) vaccines are in numerical order from lowest to highest total modRNA dose, i.e., dose level 1 represents the lowest total modRNA dose and dose level 7 represents the highest total modRNA dose. Trivalent modRNA vaccines identified as formulation 3 encode for additional influenza strain-specific antigens.
Recruitment Details
This study was conducted across 3 sub studies: Substudy A (SSA), Substudy B (SSB) and Substudy C (SSC). A total of 1202 participants (SSA = 481; SSB = 450; SSC =271) were enrolled. Each participant was enrolled in only one substudy and randomized to a single study group.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
SSA: Influenza ModRNA Vaccine 2A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 1 (preformulated) intramuscularly on Day 1.
FG001
SSA: Influenza ModRNA Vaccine 3A
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Randomized participants
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 26, 2024
Jan 15, 2026
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Quadruple
Masking Description
This study will be an observer-blinded and Sponsor-unblinded study.
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSB: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSC: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSA: Percentage of Participants With Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
From study vaccination on Day 1 through 4 weeks after study vaccination
SSB: Percentage of Participants With AEs From Vaccination Through 4 Weeks After Vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
From study vaccination on Day 1 through 4 weeks after study vaccination
SSC: Percentage of Participants With AEs From Vaccination Through 4 Weeks After Vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
From study vaccination on Day 1 through 4 weeks after study vaccination
SSA: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
From study vaccination on Day 1 through 6 months after study vaccination
SSB: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
From study vaccination on Day 1 through 6 months after study vaccination
SSC: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
From study vaccination on Day 1 through 6 months after study vaccination
SSA: Percentage of Participants With Medically Attended Adverse Events (MAEs) From Vaccination Through 6 Months After Vaccination
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
From study vaccination on Day 1 through 6 months after study vaccination
SSB: Percentage of Participants With MAEs From Vaccination Through 6 Months After Vaccination
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
From study vaccination on Day 1 through 6 months after study vaccination
SSC: Percentage of Participants With MAEs From Vaccination Through 6 Months After Vaccination
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
From study vaccination on Day 1 through 6 months after study vaccination
SSA: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination Through 6 Months After Vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
From study vaccination on Day 1 through 6 months after study vaccination
SSB: Percentage of Participants With NDCMCs From Vaccination Through 6 Months After Vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
From study vaccination on Day 1 through 6 months after study vaccination
SSC: Percentage of Participants With NDCMCs From Vaccination Through 6 Months After Vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
From study vaccination on Day 1 through 6 months after study vaccination
SSA: Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination
GMFR was defined as the geometric mean of the fold rise in the assay results from before vaccination to a specified time point after vaccination.
From before study vaccination on Day 1 up to 4 weeks after study vaccination
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with at least a 4-fold rise at the time point of interest.
4 weeks after study vaccination
SSA: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
This measure is for percentage of participants achieving HAI titers >=1:40 for each strain.
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
SSB: GMTs of Strain-Specific HAI Titers at Baseline and 4 Weeks After Vaccination
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
SSB: GMFRs of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination
From before study vaccination on Day 1 up to 4 weeks after study vaccination
SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination
4 weeks after study vaccination
SSB: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
This measure is for percentage of participants achieving HAI titers >=1:40 for each strain.
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
Scottsdale
Arizona
85260
United States
Anaheim Clinical Trials, LLC
Anaheim
California
92801
United States
Orange County Research Center
Lake Forest
California
92630
United States
Artemis Institute for Clinical Research
San Diego
California
92103
United States
Diablo Clinical Research, Inc.
Walnut Creek
California
94598
United States
Clinical Research Consulting
Milford
Connecticut
06460
United States
Indago Research & Health Center, Inc
Hialeah
Florida
33012
United States
Research Centers of America ( Hollywood )
Hollywood
Florida
33024
United States
Research Centers of America
Hollywood
Florida
33024
United States
Palm Springs Community Health Center
Miami Lakes
Florida
33014
United States
Clinical Neuroscience Solutions, Inc.
Orlando
Florida
32801
United States
Headlands Research Orlando
Orlando
Florida
32819
United States
Qps-Mra, Llc
South Miami
Florida
33143
United States
East-West Medical Research Institute
Honolulu
Hawaii
96814
United States
Alliance for Multispecialty Research, LLC
New Orleans
Louisiana
70119
United States
Prism Research LLC dba Nucleus Network
Saint Paul
Minnesota
55114
United States
Clinical Research Professionals
Chesterfield
Missouri
63005
United States
Alliance for Multispecialty Research, LLC
Kansas City
Missouri
64114
United States
Rochester Clinical Research, LLC
Rochester
New York
14609
United States
Duke Vaccine and Trials Unit
Durham
North Carolina
27703
United States
M3 Wake Research, Inc.
Raleigh
North Carolina
27612
United States
DM Clinical Research - Philadelphia
Philadelphia
Pennsylvania
19107
United States
Headlands Horizons LLC
Brownsville
Texas
78526
United States
SMS Clinical Research
Mesquite
Texas
75149
United States
Clinical Trials of Texas, LLC dba Flourish Research
San Antonio
Texas
78229
United States
Clinical Trials of Texas, LLC
San Antonio
Texas
78229
United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Tomball
Texas
77375
United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City
Utah
84109
United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City
Utah
84121
United States
Charlottesville Medical Research
Charlottesville
Virginia
22911
United States
AMR Clinical
Norfolk
Virginia
23502
United States
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
FG002
SSA: Influenza ModRNA Vaccine 4A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
FG003
SSA: Influenza ModRNA Vaccine 5A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 1 intramuscularly on Day 1.
FG004
SSA: QIV 1
Participants aged 18 to 64 years were randomized to receive a single dose of licensed standard-dose quadrivalent influenza vaccine (QIV 1) at licensed dose intramuscularly on Day 1.
FG005
SSB: Influenza ModRNA Vaccine 3B
Participants aged more than or equal to (>=) 65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
FG006
SSB: Influenza ModRNA Vaccine 4B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
FG007
SSB: Influenza ModRNA Vaccine 5B
Participants aged >=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
FG008
SSB: QIV 2
Participants aged >=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
FG009
SSB: QIV 3
Participants aged >=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
FG010
SSC: Influenza ModRNA Vaccine 3C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
FG011
SSC: Influenza ModRNA Vaccine 4C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
FG012
SSC: Influenza ModRNA Vaccine 5C
Participants aged >=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
FG013
SSC: Influenza ModRNA Vaccine 6C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 5, formulation 3 intramuscularly on Day 1.
FG014
SSC: Influenza ModRNA Vaccine 7C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 4, formulation 3 intramuscularly on Day 1.
FG015
SSC: Influenza ModRNA Vaccine 8C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
FG016
SSC: Influenza ModRNA Vaccine 9C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
FG017
SSC: QIV 2
Participants aged >=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
FG018
SSC: QIV 3
Participants aged >=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
FG00097 subjects
FG00197 subjects
FG00296 subjects
FG00397 subjects
FG00494 subjects
FG00590 subjects
FG00687 subjects
FG00790 subjects
FG00889 subjects
FG00994 subjects
FG01030 subjects
FG01130 subjects
FG01230 subjects
FG01330 subjects
FG01430 subjects
FG01530 subjects
FG01631 subjects
FG01730 subjects
FG01830 subjects
Vaccinated
FG00096 subjects
FG00196 subjects
FG00296 subjects
FG00397 subjects
FG00494 subjects
FG00590 subjects
FG00687 subjects
FG00790 subjects
FG00889 subjects
FG00994 subjects
FG01030 subjects
FG01130 subjects
FG01230 subjects
FG01330 subjects
FG01430 subjects
FG01530 subjects
FG01631 subjects
FG01730 subjects
FG01830 subjects
COMPLETED
FG00091 subjects
FG00191 subjects
FG00292 subjects
FG00392 subjects
FG00489 subjects
FG00590 subjects
FG00686 subjects
FG00788 subjects
FG00889 subjects
FG00993 subjects
FG01030 subjects
FG01129 subjects
FG01229 subjects
FG01330 subjects
FG01430 subjects
FG01529 subjects
FG01630 subjects
FG01730 subjects
FG01827 subjects
NOT COMPLETED
FG0006 subjects
FG0016 subjects
FG0024 subjects
FG0035 subjects
FG0045 subjects
FG0050 subjects
FG0061 subjects
FG0072 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0111 subjects
FG0121 subjects
FG0130 subjects
FG0140 subjects
FG0151 subjects
FG0161 subjects
FG0170 subjects
FG0183 subjects
Type
Comment
Reasons
Not Vaccinated
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0004 subjects
FG0014 subjects
FG0023 subjects
FG0034 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
No longer met eligibility criteria
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Safety population included all participants who received the study intervention.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
SSA: Influenza ModRNA Vaccine 2A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 1 (preformulated) intramuscularly on Day 1.
BG001
SSA: Influenza ModRNA Vaccine 3A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
BG002
SSA: Influenza ModRNA Vaccine 4A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
BG003
SSA: Influenza ModRNA Vaccine 5A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 1 intramuscularly on Day 1.
BG004
SSA: QIV 1
Participants aged 18 to 64 years were randomized to receive a single dose of licensed standard-dose QIV (QIV 1) at licensed dose intramuscularly on Day 1.
BG005
SSB: Influenza ModRNA Vaccine 3B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
BG006
SSB: Influenza ModRNA Vaccine 4B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
BG007
SSB: Influenza ModRNA Vaccine 5B
Participants aged >=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
BG008
SSB: QIV 2
Participants aged >=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
BG009
SSB: QIV 3
Participants aged >=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
BG010
SSC: Influenza ModRNA Vaccine 3C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
BG011
SSC: Influenza ModRNA Vaccine 4C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
BG012
SSC: Influenza ModRNA Vaccine 5C
Participants aged >=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
BG013
SSC: Influenza ModRNA Vaccine 6C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 5, formulation 3 intramuscularly on Day 1.
BG014
SSC: Influenza ModRNA Vaccine 7C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 4, formulation 3 intramuscularly on Day 1.
BG015
SSC: Influenza ModRNA Vaccine 8C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
BG016
SSC: Influenza ModRNA Vaccine 9C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
BG017
SSC: QIV 2
Participants aged >=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
BG018
SSC: QIV 3
Participants aged >=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
BG019
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00096
BG00196
BG00296
BG00397
BG00494
BG00590
BG00687
BG00790
BG00889
BG00994
BG01030
BG01130
BG01230
BG01330
BG01430
BG01530
BG01631
BG01730
BG01830
BG0191200
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00044.6± 12.42
BG00144.2± 12.44
BG00244.9± 12.43
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00062
BG00153
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00010
BG00117
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
SSA: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the electronic dairy (e-diary) or by investigators in case report form (CRF) after vaccination. All local reactions were graded based on center for biologics evaluation and research (CBER) toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
Safety population included all participants who received the study intervention. Here "Overall Number of Participants Analyzed" signifies number of participants reporting at least 1 response (yes or no) in the e-diary or CRF after vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
ID
Title
Description
OG000
SSA: Influenza ModRNA Vaccine 2A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 1 (preformulated) intramuscularly on Day 1.
OG001
SSA: Influenza ModRNA Vaccine 3A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
OG002
SSA: Influenza ModRNA Vaccine 4A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG003
SSA: Influenza ModRNA Vaccine 5A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 1 intramuscularly on Day 1.
OG004
SSA: QIV 1
Participants aged 18 to 64 years were randomized to receive a single dose of licensed standard-dose QIV (QIV 1) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00096
OG00194
OG00296
OG003
Title
Denominators
Categories
Title
Measurements
OG00083.3(74.4 to 90.2)
OG00184.0(75.0 to 90.8)
OG00280.2(70.8 to 87.6)
OG003
Primary
SSB: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. All local reactions were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
Safety population included all participants who received the study intervention. Here "Overall Number of Participants Analyzed" signifies number of participants reporting at least 1 response (yes or no) in the e-diary or CRF after vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
ID
Title
Description
OG000
SSB: Influenza ModRNA Vaccine 3B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
OG001
SSB: Influenza ModRNA Vaccine 4B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
Primary
SSC: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. All local reactions were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
Safety population included all participants who received the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
ID
Title
Description
OG000
SSC: Influenza ModRNA Vaccine 3C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG001
SSC: Influenza ModRNA Vaccine 4C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
OG002
SSC: Influenza ModRNA Vaccine 5C
Primary
SSA: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
Safety population included all participants who received the study intervention. Here "Overall Number of Participants Analyzed" signifies number of participants reporting at least 1 response (yes or no) in the e-diary or CRF after vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
ID
Title
Description
OG000
SSA: Influenza ModRNA Vaccine 2A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 1 (preformulated) intramuscularly on Day 1.
OG001
SSA: Influenza ModRNA Vaccine 3A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
Primary
SSB: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
Safety population included all participants who received the study intervention. Here "Overall Number of Participants Analyzed" signifies number of participants reporting at least 1 response (yes or no) in the e-diary or CRF after vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
ID
Title
Description
OG000
SSB: Influenza ModRNA Vaccine 3B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
OG001
SSB: Influenza ModRNA Vaccine 4B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
Primary
SSC: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
Safety population included all participants who received the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
ID
Title
Description
OG000
SSC: Influenza ModRNA Vaccine 3C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG001
SSC: Influenza ModRNA Vaccine 4C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
OG002
SSC: Influenza ModRNA Vaccine 5C
Primary
SSA: Percentage of Participants With Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
Safety population included all participants who received the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination on Day 1 through 4 weeks after study vaccination
ID
Title
Description
OG000
SSA: Influenza ModRNA Vaccine 2A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 1 (preformulated) intramuscularly on Day 1.
OG001
SSA: Influenza ModRNA Vaccine 3A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
OG002
SSA: Influenza ModRNA Vaccine 4A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
Primary
SSB: Percentage of Participants With AEs From Vaccination Through 4 Weeks After Vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
Safety population included all participants who received the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination on Day 1 through 4 weeks after study vaccination
ID
Title
Description
OG000
SSB: Influenza ModRNA Vaccine 3B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
OG001
SSB: Influenza ModRNA Vaccine 4B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG002
SSB: Influenza ModRNA Vaccine 5B
Participants aged >=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
Primary
SSC: Percentage of Participants With AEs From Vaccination Through 4 Weeks After Vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
Safety population included all participants who received the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination on Day 1 through 4 weeks after study vaccination
ID
Title
Description
OG000
SSC: Influenza ModRNA Vaccine 3C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG001
SSC: Influenza ModRNA Vaccine 4C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
OG002
SSC: Influenza ModRNA Vaccine 5C
Participants aged >=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
Primary
SSA: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
Safety population included all participants who received the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination on Day 1 through 6 months after study vaccination
ID
Title
Description
OG000
SSA: Influenza ModRNA Vaccine 2A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 1 (preformulated) intramuscularly on Day 1.
OG001
SSA: Influenza ModRNA Vaccine 3A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
OG002
SSA: Influenza ModRNA Vaccine 4A
Primary
SSB: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
Safety population included all participants who received the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination on Day 1 through 6 months after study vaccination
ID
Title
Description
OG000
SSB: Influenza ModRNA Vaccine 3B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
OG001
SSB: Influenza ModRNA Vaccine 4B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG002
SSB: Influenza ModRNA Vaccine 5B
Primary
SSC: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
Safety population included all participants who received the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination on Day 1 through 6 months after study vaccination
ID
Title
Description
OG000
SSC: Influenza ModRNA Vaccine 3C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG001
SSC: Influenza ModRNA Vaccine 4C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
OG002
SSC: Influenza ModRNA Vaccine 5C
Primary
SSA: Percentage of Participants With Medically Attended Adverse Events (MAEs) From Vaccination Through 6 Months After Vaccination
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Safety population included all participants who received the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination on Day 1 through 6 months after study vaccination
ID
Title
Description
OG000
SSA: Influenza ModRNA Vaccine 2A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 1 (preformulated) intramuscularly on Day 1.
OG001
SSA: Influenza ModRNA Vaccine 3A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
OG002
SSA: Influenza ModRNA Vaccine 4A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
Primary
SSB: Percentage of Participants With MAEs From Vaccination Through 6 Months After Vaccination
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Safety population included all participants who received the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination on Day 1 through 6 months after study vaccination
ID
Title
Description
OG000
SSB: Influenza ModRNA Vaccine 3B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
OG001
SSB: Influenza ModRNA Vaccine 4B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG002
SSB: Influenza ModRNA Vaccine 5B
Participants aged >=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG003
Primary
SSC: Percentage of Participants With MAEs From Vaccination Through 6 Months After Vaccination
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Safety population included all participants who received the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination on Day 1 through 6 months after study vaccination
ID
Title
Description
OG000
SSC: Influenza ModRNA Vaccine 3C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG001
SSC: Influenza ModRNA Vaccine 4C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
OG002
SSC: Influenza ModRNA Vaccine 5C
Participants aged >=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
OG003
SSC: Influenza ModRNA Vaccine 6C
Primary
SSA: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination Through 6 Months After Vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
Safety population included all participants who received the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination on Day 1 through 6 months after study vaccination
ID
Title
Description
OG000
SSA: Influenza ModRNA Vaccine 2A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 1 (preformulated) intramuscularly on Day 1.
OG001
SSA: Influenza ModRNA Vaccine 3A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
OG002
SSA: Influenza ModRNA Vaccine 4A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
Primary
SSB: Percentage of Participants With NDCMCs From Vaccination Through 6 Months After Vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
Safety population included all participants who received the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination on Day 1 through 6 months after study vaccination
ID
Title
Description
OG000
SSB: Influenza ModRNA Vaccine 3B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
OG001
SSB: Influenza ModRNA Vaccine 4B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG002
SSB: Influenza ModRNA Vaccine 5B
Participants aged >=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
Primary
SSC: Percentage of Participants With NDCMCs From Vaccination Through 6 Months After Vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
Safety population included all participants who received the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination on Day 1 through 6 months after study vaccination
ID
Title
Description
OG000
SSC: Influenza ModRNA Vaccine 3C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG001
SSC: Influenza ModRNA Vaccine 4C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
OG002
SSC: Influenza ModRNA Vaccine 5C
Participants aged >=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
OG003
Secondary
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at Baseline and 4 Weeks After Vaccination
GMTs and the corresponding 2-sided 95% confidence intervals (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).
Evaluable immunogenicity population: All eligible participants who received the study intervention to which they were randomized, had blood drawn for assay testing within the specified time frame after vaccination, had at least 1 valid and determinate assay result at the 4-week postvaccination visit, and had no major protocol violations. Here, Number Analyzed=number of participants evaluable for the specified rows.
Posted
Geometric Mean
95% Confidence Interval
Titers
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
ID
Title
Description
OG000
SSA: Influenza ModRNA Vaccine 2A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 1 (preformulated) intramuscularly on Day 1.
OG001
SSA: Influenza ModRNA Vaccine 3A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
Secondary
SSA: Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination
GMFR was defined as the geometric mean of the fold rise in the assay results from before vaccination to a specified time point after vaccination.
Evaluable immunogenicity population. Here, Number Analyzed=number of participants evaluable for the specified rows.
Posted
Geometric Mean
95% Confidence Interval
Fold Rise
From before study vaccination on Day 1 up to 4 weeks after study vaccination
ID
Title
Description
OG000
SSA: Influenza ModRNA Vaccine 2A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 1 (preformulated) intramuscularly on Day 1.
OG001
SSA: Influenza ModRNA Vaccine 3A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
OG002
SSA: Influenza ModRNA Vaccine 4A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
Secondary
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with at least a 4-fold rise at the time point of interest.
Evaluable immunogenicity population. Here, Number Analyzed=number of participants evaluable for the specified rows.
Posted
Number
95% Confidence Interval
Percentage of participants
4 weeks after study vaccination
ID
Title
Description
OG000
SSA: Influenza ModRNA Vaccine 2A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 1 (preformulated) intramuscularly on Day 1.
OG001
SSA: Influenza ModRNA Vaccine 3A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
OG002
SSA: Influenza ModRNA Vaccine 4A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
Secondary
SSA: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
This measure is for percentage of participants achieving HAI titers >=1:40 for each strain.
Evaluable immunogenicity population. Here, Number Analyzed=number of participants evaluable for the specified rows.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
ID
Title
Description
OG000
SSA: Influenza ModRNA Vaccine 2A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 1 (preformulated) intramuscularly on Day 1.
OG001
SSA: Influenza ModRNA Vaccine 3A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
OG002
SSA: Influenza ModRNA Vaccine 4A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
Secondary
SSB: GMTs of Strain-Specific HAI Titers at Baseline and 4 Weeks After Vaccination
Evaluable immunogenicity population. Here, Number Analyzed=number of participants evaluable for the specified rows.
Posted
Geometric Mean
95% Confidence Interval
Titers
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
ID
Title
Description
OG000
SSB: Influenza ModRNA Vaccine 3B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
OG001
SSB: Influenza ModRNA Vaccine 4B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG002
SSB: Influenza ModRNA Vaccine 5B
Participants aged >=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG003
SSB: QIV 2
Participants aged >=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
Secondary
SSB: GMFRs of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination
Evaluable immunogenicity population. Here, Number Analyzed=number of participants evaluable for the specified rows.
Posted
Geometric Mean
95% Confidence Interval
Fold Rise
From before study vaccination on Day 1 up to 4 weeks after study vaccination
ID
Title
Description
OG000
SSB: Influenza ModRNA Vaccine 3B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
OG001
SSB: Influenza ModRNA Vaccine 4B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG002
SSB: Influenza ModRNA Vaccine 5B
Participants aged >=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG003
SSB: QIV 2
Secondary
SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination
Evaluable immunogenicity population. Here, Number Analyzed=number of participants evaluable for the specified rows.
Posted
Number
95% Confidence Interval
Percentage of participants
4 weeks after study vaccination
ID
Title
Description
OG000
SSB: Influenza ModRNA Vaccine 3B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
OG001
SSB: Influenza ModRNA Vaccine 4B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG002
SSB: Influenza ModRNA Vaccine 5B
Participants aged >=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG003
SSB: QIV 2
Participants aged >=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
Secondary
SSB: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
This measure is for percentage of participants achieving HAI titers >=1:40 for each strain.
Evaluable immunogenicity population. Here, Number Analyzed=number of participants evaluable for the specified rows.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
ID
Title
Description
OG000
SSB: Influenza ModRNA Vaccine 3B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
OG001
SSB: Influenza ModRNA Vaccine 4B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG002
SSB: Influenza ModRNA Vaccine 5B
Participants aged >=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
Time Frame
Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Description
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
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
SSA: Influenza ModRNA Vaccine 2A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 1 (preformulated) intramuscularly on Day 1.
0
96
2
96
88
96
EG001
SSA: Influenza ModRNA Vaccine 3A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
0
96
0
96
84
96
EG002
SSA: Influenza ModRNA Vaccine 4A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
0
96
0
96
86
96
EG003
SSA: Influenza ModRNA Vaccine 5A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 1 intramuscularly on Day 1.
0
97
0
97
82
97
EG004
SSA: QIV 1
Participants aged 18 to 64 years were randomized to receive a single dose of licensed standard-dose QIV (QIV 1) at licensed dose intramuscularly on Day 1.
0
94
0
94
63
94
EG005
SSB: Influenza ModRNA Vaccine 3B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
0
90
0
90
76
90
EG006
SSB: Influenza ModRNA Vaccine 4B
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
0
87
4
87
67
87
EG007
SSB: Influenza ModRNA Vaccine 5B
Participants aged >=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
0
90
4
90
68
90
EG008
SSB: QIV 2
Participants aged >=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
0
89
3
89
47
89
EG009
SSB: QIV 3
Participants aged >=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
0
94
2
94
50
94
EG010
SSC: Influenza ModRNA Vaccine 3C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
0
30
0
30
24
30
EG011
SSC: Influenza ModRNA Vaccine 4C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
0
30
0
30
19
30
EG012
SSC: Influenza ModRNA Vaccine 5C
Participants aged >=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
0
30
0
30
25
30
EG013
SSC: Influenza ModRNA Vaccine 6C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 5, formulation 3 intramuscularly on Day 1.
0
30
2
30
25
30
EG014
SSC: Influenza ModRNA Vaccine 7C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 4, formulation 3 intramuscularly on Day 1.
0
30
0
30
26
30
EG015
SSC: Influenza ModRNA Vaccine 8C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
0
30
1
30
27
30
EG016
SSC: Influenza ModRNA Vaccine 9C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
0
31
1
31
24
31
EG017
SSC: QIV 2
Participants aged >=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
0
30
0
30
17
30
EG018
SSC: QIV 3
Participants aged >=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
0
30
0
30
17
30
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected96 at risk
EG0010 affected96 at risk
EG0020 affected96 at risk
EG0030 affected97 at risk
EG0040 affected94 at risk
EG0050 affected90 at risk
EG0060 affected87 at risk
EG0071 affected90 at risk
EG0080 affected89 at risk
EG0090 affected94 at risk
EG0100 affected30 at risk
EG0110 affected30 at risk
EG0120 affected30 at risk
EG0130 affected30 at risk
EG0140 affected30 at risk
EG0150 affected30 at risk
EG0160 affected31 at risk
EG0170 affected30 at risk
EG0180 affected30 at risk
Sinus node dysfunction
Cardiac disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected96 at risk
EG0010 affected96 at risk
EG0020 affected96 at risk
EG003
Gastrointestinal ulcer haemorrhage
Gastrointestinal disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected96 at risk
EG0010 affected96 at risk
EG0020 affected96 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected96 at risk
EG0010 affected96 at risk
EG0020 affected96 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected96 at risk
EG0010 affected96 at risk
EG0020 affected96 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0001 affected96 at risk
EG0010 affected96 at risk
EG0020 affected96 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v27.1
Non-systematic Assessment
EG0000 affected96 at risk
EG0010 affected96 at risk
EG0020 affected96 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA v27.1
Non-systematic Assessment
EG0000 affected96 at risk
EG0010 affected96 at risk
EG0020 affected96 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA v27.1
Non-systematic Assessment
EG0000 affected96 at risk
EG0010 affected96 at risk
EG0020 affected96 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA v27.1
Non-systematic Assessment
EG0000 affected96 at risk
EG0010 affected96 at risk
EG0020 affected96 at risk
EG003
Scapula fracture
Injury, poisoning and procedural complications
MedDRA v27.1
Non-systematic Assessment
EG0000 affected96 at risk
EG0010 affected96 at risk
EG0020 affected96 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA v27.1
Non-systematic Assessment
EG0001 affected96 at risk
EG0010 affected96 at risk
EG0020 affected96 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected96 at risk
EG0010 affected96 at risk
EG0020 affected96 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected96 at risk
EG0010 affected96 at risk
EG0020 affected96 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected96 at risk
EG0010 affected96 at risk
EG0020 affected96 at risk
EG003
Follicular lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.1
Non-systematic Assessment
EG0000 affected96 at risk
EG0010 affected96 at risk
EG0020 affected96 at risk
EG003
Malignant melanoma in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.1
Non-systematic Assessment
EG0000 affected96 at risk
EG0010 affected96 at risk
EG0020 affected96 at risk
EG003
Polycythaemia vera
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.1
Non-systematic Assessment
EG0000 affected96 at risk
EG0010 affected96 at risk
EG0020 affected96 at risk
EG003
Ureteric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.1
Non-systematic Assessment
EG0000 affected96 at risk
EG0010 affected96 at risk
EG0020 affected96 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected96 at risk
EG0010 affected96 at risk
EG0020 affected96 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
MedDRA v27.1
Non-systematic Assessment
EG0000 affected96 at risk
EG0010 affected96 at risk
EG0020 affected96 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v27.1
Non-systematic Assessment
EG0001 affected96 at risk
EG0010 affected96 at risk
EG0020 affected96 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea (DIARRHEA)
Gastrointestinal disorders
MedDRA v27.1
Systematic Assessment
EG00016 affected96 at risk
EG00111 affected96 at risk
EG0025 affected96 at risk
EG00318 affected97 at risk
EG0049 affected94 at risk
EG00514 affected90 at risk
EG0068 affected87 at risk
EG0075 affected90 at risk
EG00810 affected89 at risk
EG0099 affected94 at risk
EG0100 affected30 at risk
EG0113 affected30 at risk
EG0121 affected30 at risk
EG0133 affected30 at risk
EG0142 affected30 at risk
EG0153 affected30 at risk
EG0163 affected31 at risk
EG0171 affected30 at risk
EG0181 affected30 at risk
Chills (CHILLS)
General disorders
MedDRA v27.1
Systematic Assessment
EG00026 affected96 at risk
EG00124 affected96 at risk
EG00228 affected96 at risk
EG003
Fatigue (FATIGUE)
General disorders
MedDRA v27.1
Systematic Assessment
EG00054 affected96 at risk
EG00155 affected96 at risk
EG00251 affected96 at risk
EG003
Injection site erythema (REDNESS)
General disorders
MedDRA v27.1
Systematic Assessment
EG0004 affected96 at risk
EG0012 affected96 at risk
EG0026 affected96 at risk
EG003
Injection site pain (PAIN)
General disorders
MedDRA v27.1
Systematic Assessment
EG00079 affected96 at risk
EG00179 affected96 at risk
EG00276 affected96 at risk
EG003
Injection site swelling (SWELLING)
General disorders
MedDRA v27.1
Systematic Assessment
EG00010 affected96 at risk
EG0013 affected96 at risk
EG0028 affected96 at risk
EG003
Pyrexia (FEVER)
General disorders
MedDRA v27.1
Systematic Assessment
EG00011 affected96 at risk
EG0018 affected96 at risk
EG00210 affected96 at risk
EG003
Arthralgia (JOINT PAIN)
Musculoskeletal and connective tissue disorders
MedDRA v27.1
Systematic Assessment
EG00026 affected96 at risk
EG00123 affected96 at risk
EG00217 affected96 at risk
EG003
Myalgia (MUSCLE PAIN)
Musculoskeletal and connective tissue disorders
MedDRA v27.1
Systematic Assessment
EG00037 affected96 at risk
EG00143 affected96 at risk
EG00232 affected96 at risk
EG003
Headache (HEADACHE)
Nervous system disorders
MedDRA v27.1
Systematic Assessment
EG00048 affected96 at risk
EG00146 affected96 at risk
EG00248 affected96 at risk
EG003
As per Sponsor's decision information on formulation and dose has not been disclosed in the results summary to maintain the company confidentiality.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Participants aged >=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG003
SSB: QIV 2
Participants aged >=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
OG004
SSB: QIV 3
Participants aged >=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00090
OG00186
OG00288
OG00388
OG00492
Title
Denominators
Categories
Title
Measurements
OG00066.7(55.9 to 76.3)
OG00164.0(52.9 to 74.0)
OG00268.2(57.4 to 77.7)
OG00343.2(32.7 to 54.2)
OG00442.4(32.1 to 53.1)
Participants aged >=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
OG003
SSC: Influenza ModRNA Vaccine 6C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 5, formulation 3 intramuscularly on Day 1.
OG004
SSC: Influenza ModRNA Vaccine 7C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 4, formulation 3 intramuscularly on Day 1.
OG005
SSC: Influenza ModRNA Vaccine 8C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
OG006
SSC: Influenza ModRNA Vaccine 9C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
OG007
SSC: QIV 2
Participants aged >=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
OG008
SSC: QIV 3
Participants aged >=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00030
OG00130
OG00230
OG00330
OG00430
OG00530
OG00631
OG00730
OG00830
Title
Denominators
Categories
Title
Measurements
OG00076.7(57.7 to 90.1)
OG00143.3(25.5 to 62.6)
OG00273.3(54.1 to 87.7)
OG00370.0(50.6 to 85.3)
OG00473.3(54.1 to 87.7)
OG00586.7(69.3 to 96.2)
OG00661.3(42.2 to 78.2)
OG00746.7(28.3 to 65.7)
OG00850.0(31.3 to 68.7)
OG002
SSA: Influenza ModRNA Vaccine 4A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG003
SSA: Influenza ModRNA Vaccine 5A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 1 intramuscularly on Day 1.
OG004
SSA: QIV 1
Participants aged 18 to 64 years were randomized to receive a single dose of licensed standard-dose QIV (QIV 1) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00096
OG00194
OG00296
OG00397
OG00494
Title
Denominators
Categories
Title
Measurements
OG00068.8(58.5 to 77.8)
OG00176.6(66.7 to 84.7)
OG00276.0(66.3 to 84.2)
OG00375.3(65.5 to 83.5)
OG00453.2(42.6 to 63.6)
OG002
SSB: Influenza ModRNA Vaccine 5B
Participants aged >=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG003
SSB: QIV 2
Participants aged >=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
OG004
SSB: QIV 3
Participants aged >=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00090
OG00186
OG00288
OG00388
OG00492
Title
Denominators
Categories
Title
Measurements
OG00056.7(45.8 to 67.1)
OG00158.1(47.0 to 68.7)
OG00258.0(47.0 to 68.4)
OG00333.0(23.3 to 43.8)
OG00434.8(25.1 to 45.4)
Participants aged >=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
OG003
SSC: Influenza ModRNA Vaccine 6C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 5, formulation 3 intramuscularly on Day 1.
OG004
SSC: Influenza ModRNA Vaccine 7C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 4, formulation 3 intramuscularly on Day 1.
OG005
SSC: Influenza ModRNA Vaccine 8C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
OG006
SSC: Influenza ModRNA Vaccine 9C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
OG007
SSC: QIV 2
Participants aged >=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
OG008
SSC: QIV 3
Participants aged >=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00030
OG00130
OG00230
OG00330
OG00430
OG00530
OG00631
OG00730
OG00830
Title
Denominators
Categories
Title
Measurements
OG00056.7(37.4 to 74.5)
OG00153.3(34.3 to 71.7)
OG00263.3(43.9 to 80.1)
OG00353.3(34.3 to 71.7)
OG00456.7(37.4 to 74.5)
OG00580.0(61.4 to 92.3)
OG00661.3(42.2 to 78.2)
OG00743.3(25.5 to 62.6)
OG00836.7(19.9 to 56.1)
OG003
SSA: Influenza ModRNA Vaccine 5A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 1 intramuscularly on Day 1.
OG004
SSA: QIV 1
Participants aged 18 to 64 years were randomized to receive a single dose of licensed standard-dose QIV (QIV 1) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00096
OG00196
OG00296
OG00397
OG00494
Title
Denominators
Categories
Title
Measurements
OG0005.2(1.7 to 11.7)
OG0018.3(3.7 to 15.8)
OG0023.1(0.6 to 8.9)
OG0038.2(3.6 to 15.6)
OG0046.4(2.4 to 13.4)
OG003
SSB: QIV 2
Participants aged >=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
OG004
SSB: QIV 3
Participants aged >=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00090
OG00187
OG00290
OG00389
OG00494
Title
Denominators
Categories
Title
Measurements
OG0008.9(3.9 to 16.8)
OG0018.0(3.3 to 15.9)
OG0028.9(3.9 to 16.8)
OG0036.7(2.5 to 14.1)
OG0044.3(1.2 to 10.5)
OG003
SSC: Influenza ModRNA Vaccine 6C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 5, formulation 3 intramuscularly on Day 1.
OG004
SSC: Influenza ModRNA Vaccine 7C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 4, formulation 3 intramuscularly on Day 1.
OG005
SSC: Influenza ModRNA Vaccine 8C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
OG006
SSC: Influenza ModRNA Vaccine 9C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
OG007
SSC: QIV 2
Participants aged >=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
OG008
SSC: QIV 3
Participants aged >=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00030
OG00130
OG00230
OG00330
OG00430
OG00530
OG00631
OG00730
OG00830
Title
Denominators
Categories
Title
Measurements
OG0006.7(0.8 to 22.1)
OG00110.0(2.1 to 26.5)
OG00210.0(2.1 to 26.5)
OG00310.0(2.1 to 26.5)
OG0040(0.0 to 11.6)
OG0056.7(0.8 to 22.1)
OG0063.2(0.1 to 16.7)
OG0073.3(0.1 to 17.2)
OG00810.0(2.1 to 26.5)
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG003
SSA: Influenza ModRNA Vaccine 5A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 1 intramuscularly on Day 1.
OG004
SSA: QIV 1
Participants aged 18 to 64 years were randomized to receive a single dose of licensed standard-dose QIV (QIV 1) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00096
OG00196
OG00296
OG00397
OG00494
Title
Denominators
Categories
Title
Measurements
OG0002.1(0.3 to 7.3)
OG0010(0.0 to 3.8)
OG0020(0.0 to 3.8)
OG0030(0.0 to 3.7)
OG0040(0.0 to 3.8)
Participants aged >=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG003
SSB: QIV 2
Participants aged >=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
OG004
SSB: QIV 3
Participants aged >=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00090
OG00187
OG00290
OG00389
OG00494
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 4.0)
OG0014.6(1.3 to 11.4)
OG0024.4(1.2 to 11.0)
OG0033.4(0.7 to 9.5)
OG0042.1(0.3 to 7.5)
Participants aged >=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
OG003
SSC: Influenza ModRNA Vaccine 6C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 5, formulation 3 intramuscularly on Day 1.
OG004
SSC: Influenza ModRNA Vaccine 7C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 4, formulation 3 intramuscularly on Day 1.
OG005
SSC: Influenza ModRNA Vaccine 8C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
OG006
SSC: Influenza ModRNA Vaccine 9C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
OG007
SSC: QIV 2
Participants aged >=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
OG008
SSC: QIV 3
Participants aged >=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00030
OG00130
OG00230
OG00330
OG00430
OG00530
OG00631
OG00730
OG00830
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 11.6)
OG0010(0.0 to 11.6)
OG0020(0.0 to 11.6)
OG0036.7(0.8 to 22.1)
OG0040(0.0 to 11.6)
OG0053.3(0.1 to 17.2)
OG0063.2(0.1 to 16.7)
OG0070(0.0 to 11.6)
OG0080(0.0 to 11.6)
OG003
SSA: Influenza ModRNA Vaccine 5A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 1 intramuscularly on Day 1.
OG004
SSA: QIV 1
Participants aged 18 to 64 years were randomized to receive a single dose of licensed standard-dose QIV (QIV 1) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00096
OG00196
OG00296
OG00397
OG00494
Title
Denominators
Categories
Title
Measurements
OG0005.2(1.7 to 11.7)
OG0019.4(4.4 to 17.1)
OG0023.1(0.6 to 8.9)
OG0038.2(3.6 to 15.6)
OG0046.4(2.4 to 13.4)
SSB: QIV 2
Participants aged >=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
OG004
SSB: QIV 3
Participants aged >=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00090
OG00187
OG00290
OG00389
OG00494
Title
Denominators
Categories
Title
Measurements
OG00010.0(4.7 to 18.1)
OG00112.6(6.5 to 21.5)
OG0027.8(3.2 to 15.4)
OG00311.2(5.5 to 19.7)
OG0047.4(3.0 to 14.7)
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 5, formulation 3 intramuscularly on Day 1.
OG004
SSC: Influenza ModRNA Vaccine 7C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 4, formulation 3 intramuscularly on Day 1.
OG005
SSC: Influenza ModRNA Vaccine 8C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
OG006
SSC: Influenza ModRNA Vaccine 9C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
OG007
SSC: QIV 2
Participants aged >=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
OG008
SSC: QIV 3
Participants aged >=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00030
OG00130
OG00230
OG00330
OG00430
OG00530
OG00631
OG00730
OG00830
Title
Denominators
Categories
Title
Measurements
OG00010.0(2.1 to 26.5)
OG0016.7(0.8 to 22.1)
OG00216.7(5.6 to 34.7)
OG0036.7(0.8 to 22.1)
OG0040(0.0 to 11.6)
OG0056.7(0.8 to 22.1)
OG0066.5(0.8 to 21.4)
OG0073.3(0.1 to 17.2)
OG0083.3(0.1 to 17.2)
OG003
SSA: Influenza ModRNA Vaccine 5A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 1 intramuscularly on Day 1.
OG004
SSA: QIV 1
Participants aged 18 to 64 years were randomized to receive a single dose of licensed standard-dose QIV (QIV 1) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00096
OG00196
OG00296
OG00397
OG00494
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 3.8)
OG0010(0.0 to 3.8)
OG0020(0.0 to 3.8)
OG0034.1(1.1 to 10.2)
OG0041.1(0.0 to 5.8)
OG003
SSB: QIV 2
Participants aged >=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
OG004
SSB: QIV 3
Participants aged >=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00090
OG00187
OG00290
OG00389
OG00494
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 4.0)
OG0011.1(0.0 to 6.2)
OG0022.2(0.3 to 7.8)
OG0033.4(0.7 to 9.5)
OG0042.1(0.3 to 7.5)
SSC: Influenza ModRNA Vaccine 6C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 5, formulation 3 intramuscularly on Day 1.
OG004
SSC: Influenza ModRNA Vaccine 7C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 4, formulation 3 intramuscularly on Day 1.
OG005
SSC: Influenza ModRNA Vaccine 8C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
OG006
SSC: Influenza ModRNA Vaccine 9C
Participants aged >=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
OG007
SSC: QIV 2
Participants aged >=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
OG008
SSC: QIV 3
Participants aged >=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00030
OG00130
OG00230
OG00330
OG00430
OG00530
OG00631
OG00730
OG00830
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 11.6)
OG0013.3(0.1 to 17.2)
OG0020(0.0 to 11.6)
OG0030(0.0 to 11.6)
OG0040(0.0 to 11.6)
OG0050(0.0 to 11.6)
OG0060(0.0 to 11.2)
OG0073.3(0.1 to 17.2)
OG0080(0.0 to 11.6)
OG002
SSA: Influenza ModRNA Vaccine 4A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
OG003
SSA: Influenza ModRNA Vaccine 5A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 1 intramuscularly on Day 1.
OG004
SSA: QIV 1
Participants aged 18 to 64 years were randomized to receive a single dose of licensed standard-dose QIV (QIV 1) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00086
OG00188
OG00284
OG00385
OG00485
Title
Denominators
Categories
A/H1N1: Before Vaccination
ParticipantsOG00086
ParticipantsOG00188
ParticipantsOG00283
ParticipantsOG00385
ParticipantsOG00485
Title
Measurements
OG00026.7(20.4 to 35.0)
OG00124.2(18.7 to 31.3)
OG00229.4(22.8 to 37.9)
OG003
A/H1N1: 4 Weeks After Vaccination
ParticipantsOG00086
ParticipantsOG00188
ParticipantsOG00284
ParticipantsOG00385
A/H3N2: Before Vaccination
ParticipantsOG00086
ParticipantsOG00188
ParticipantsOG00283
ParticipantsOG00385
A/H3N2: 4 Weeks After Vaccination
ParticipantsOG00086
ParticipantsOG00188
ParticipantsOG00284
ParticipantsOG00383
B/Victoria: Before Vaccination
ParticipantsOG00086
ParticipantsOG00188
ParticipantsOG00284
ParticipantsOG00385
B/Victoria: 4 Weeks After Vaccination
ParticipantsOG00086
ParticipantsOG00188
ParticipantsOG00284
ParticipantsOG00385
B/Yamagata: Before Vaccination
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00284
ParticipantsOG00385
B/Yamagata: 4 Weeks After Vaccination
ParticipantsOG00086
ParticipantsOG00188
ParticipantsOG00284
ParticipantsOG00385
OG003
SSA: Influenza ModRNA Vaccine 5A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 1 intramuscularly on Day 1.
OG004
SSA: QIV 1
Participants aged 18 to 64 years were randomized to receive a single dose of licensed standard-dose QIV (QIV 1) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00086
OG00188
OG00284
OG00385
OG00485
Title
Denominators
Categories
A/H1N1
ParticipantsOG00086
ParticipantsOG00188
ParticipantsOG00283
ParticipantsOG00385
ParticipantsOG00485
Title
Measurements
OG0005.4(4.4 to 6.7)
OG0015.6(4.5 to 6.9)
OG0026.1(4.8 to 7.7)
OG003
A/H3N2
ParticipantsOG00086
ParticipantsOG00188
ParticipantsOG00283
ParticipantsOG00383
B/Victoria
ParticipantsOG00086
ParticipantsOG00188
ParticipantsOG00284
ParticipantsOG00385
B/Yamagata
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00284
ParticipantsOG00385
OG003
SSA: Influenza ModRNA Vaccine 5A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 1 intramuscularly on Day 1.
OG004
SSA: QIV 1
Participants aged 18 to 64 years were randomized to receive a single dose of licensed standard-dose QIV (QIV 1) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00086
OG00188
OG00284
OG00385
OG00485
Title
Denominators
Categories
A/H1N1
ParticipantsOG00086
ParticipantsOG00188
ParticipantsOG00283
ParticipantsOG00385
ParticipantsOG00485
Title
Measurements
OG00072.1(61.4 to 81.2)
OG00175.0(64.6 to 83.6)
OG00278.3(67.9 to 86.6)
OG003
A/H3N2
ParticipantsOG00086
ParticipantsOG00188
ParticipantsOG00283
ParticipantsOG00383
B/Victoria
ParticipantsOG00086
ParticipantsOG00188
ParticipantsOG00284
ParticipantsOG00385
B/Yamagata
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00284
ParticipantsOG00385
OG003
SSA: Influenza ModRNA Vaccine 5A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 1 intramuscularly on Day 1.
OG004
SSA: QIV 1
Participants aged 18 to 64 years were randomized to receive a single dose of licensed standard-dose QIV (QIV 1) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00086
OG00188
OG00284
OG00385
OG00485
Title
Denominators
Categories
A/H1N1: Before Vaccination
ParticipantsOG00086
ParticipantsOG00188
ParticipantsOG00283
ParticipantsOG00385
ParticipantsOG00485
Title
Measurements
OG00048.8(37.9 to 59.9)
OG00145.5(34.8 to 56.4)
OG00255.4(44.1 to 66.3)
OG003
A/H1N1: 4 Weeks After Vaccination
ParticipantsOG00086
ParticipantsOG00188
ParticipantsOG00284
ParticipantsOG00385
A/H3N2: Before Vaccination
ParticipantsOG00086
ParticipantsOG00188
ParticipantsOG00283
ParticipantsOG00385
A/H3N2: 4 Weeks After Vaccination
ParticipantsOG00086
ParticipantsOG00188
ParticipantsOG00284
ParticipantsOG00383
B/Victoria: Before Vaccination
ParticipantsOG00086
ParticipantsOG00188
ParticipantsOG00284
ParticipantsOG00385
B/Victoria: 4 Weeks After Vaccination
ParticipantsOG00086
ParticipantsOG00188
ParticipantsOG00284
ParticipantsOG00385
B/Yamagata: Before Vaccination
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00284
ParticipantsOG00385
B/Yamagata: 4 Weeks After Vaccination
ParticipantsOG00086
ParticipantsOG00188
ParticipantsOG00284
ParticipantsOG00385
OG004
SSB: QIV 3
Participants aged >=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00087
OG00178
OG00283
OG00387
OG00490
Title
Denominators
Categories
A/H1N1: Before Vaccination
ParticipantsOG00086
ParticipantsOG00175
ParticipantsOG00283
ParticipantsOG00387
ParticipantsOG00489
Title
Measurements
OG00023.2(17.9 to 30.1)
OG00121.3(16.2 to 28.1)
OG00222.3(16.7 to 29.8)
OG003
A/H1N1: 4 Weeks After Vaccination
ParticipantsOG00086
ParticipantsOG00178
ParticipantsOG00283
ParticipantsOG00386
A/H3N2: Before Vaccination
ParticipantsOG00087
ParticipantsOG00178
ParticipantsOG00283
ParticipantsOG00387
A/H3N2: 4 Weeks After Vaccination
ParticipantsOG00087
ParticipantsOG00178
ParticipantsOG00283
ParticipantsOG00387
B/Victoria: Before Vaccination
ParticipantsOG00087
ParticipantsOG00178
ParticipantsOG00283
ParticipantsOG00387
B/Victoria: 4 Weeks After Vaccination
ParticipantsOG00087
ParticipantsOG00178
ParticipantsOG00283
ParticipantsOG00387
B/Yamagata: Before Vaccination
ParticipantsOG00087
ParticipantsOG00177
ParticipantsOG00282
ParticipantsOG00387
B/Yamagata: 4 Weeks After Vaccination
ParticipantsOG00086
ParticipantsOG00177
ParticipantsOG00282
ParticipantsOG00386
Participants aged >=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
OG004
SSB: QIV 3
Participants aged >=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00087
OG00178
OG00283
OG00387
OG00490
Title
Denominators
Categories
A/H1N1
ParticipantsOG00085
ParticipantsOG00175
ParticipantsOG00283
ParticipantsOG00386
ParticipantsOG00489
Title
Measurements
OG0002.8(2.3 to 3.4)
OG0015.0(3.9 to 6.6)
OG0023.5(2.8 to 4.5)
OG003
A/H3N2
ParticipantsOG00087
ParticipantsOG00178
ParticipantsOG00283
ParticipantsOG00387
B/Victoria
ParticipantsOG00087
ParticipantsOG00178
ParticipantsOG00283
ParticipantsOG00387
B/Yamagata
ParticipantsOG00086
ParticipantsOG00177
ParticipantsOG00282
ParticipantsOG00386
OG004
SSB: QIV 3
Participants aged >=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
Units
Counts
Participants
OG00087
OG00178
OG00283
OG00387
OG00490
Title
Denominators
Categories
A/H1N1
ParticipantsOG00085
ParticipantsOG00175
ParticipantsOG00283
ParticipantsOG00386
ParticipantsOG00489
Title
Measurements
OG00036.5(26.3 to 47.6)
OG00158.7(46.7 to 69.9)
OG00245.8(34.8 to 57.1)
OG003
A/H3N2
ParticipantsOG00087
ParticipantsOG00178
ParticipantsOG00283
ParticipantsOG00387
B/Victoria
ParticipantsOG00087
ParticipantsOG00178
ParticipantsOG00283
ParticipantsOG00387
B/Yamagata
ParticipantsOG00086
ParticipantsOG00177
ParticipantsOG00282
ParticipantsOG00386
OG003
SSB: QIV 2
Participants aged >=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
OG004
SSB: QIV 3
Participants aged >=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.