Back to resultsA Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults
Primary Purpose
Seasonal Influenza
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
mRNA-1030
mRNA-1020
mRNA-1010
Active Comparator
Sponsored by
About this trial
This is an interventional prevention trial for Seasonal Influenza focused on measuring Influenza vaccine, mRNA-1020, mRNA-1030, Moderna
Eligibility Criteria
Inclusion Criteria:
- Body mass index of 18 kilograms (kg)/square meter (m^2) to 35 kg/m^2 (inclusive) at the Screening Visit.
- For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 90 days following vaccine administration, and not currently breastfeeding.
Exclusion Criteria:
- Participant has had close contact to someone with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) or has had a positive SARS-CoV-2 test in the past 10 days prior to the Screening Visit.
- Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.
- Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
- Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 180 days prior to screening (for corticosteroids ≥10 milligrams [mg]/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
- Participant has received or plans to receive any licensed or authorized vaccine, including COVID-19 vaccines, ≤28 days prior to the study injection (Day 1) or plans to receive a licensed or authorized vaccine within 28 days after the study injection.
- Participant has received a Northern Hemisphere (NH) 2021-2022 seasonal influenza vaccine or any other influenza vaccine within 180 days prior to Day 1.
- Participant tested positive for influenza by CDC-recommended testing methods within 180 days prior to Day 1.
- Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.
Note: Other inclusion/exclusion criteria may apply.
Sites / Locations
- Foothills Research Center
- Alliance for MultiSpecialty Research
- Health Awareness, Inc.
- IACT Health
- Meridian Clinical Research
- Heartland Research Associates, LLC
- Sundance Clinical Research, LLC
- Meridian Clinical Research
- Lucas Research
- Trial Management Associates, LLC
- Meridian Clinical Research
- Lynn Institute of Norman
- LinQ Research, LLC
- Olympus Family Medicine
- South Ogden Family Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
mRNA-1030 Dose Level A
mRNA-1020 Dose Level A
mRNA-1030 Dose Level B
mRNA-1020 Dose Level B
mRNA-1030 Dose Level C
mRNA-1020 Dose Level C
mRNA-1010
Active Comparator
Arm Description
Participants will receive mRNA-1030 at Dose Level A by intramuscular (IM) injection on Day 1.
Participants will receive mRNA-1020 at Dose Level A by IM injection on Day 1.
Participants will receive mRNA-1030 at Dose Level B by IM injection on Day 1.
Participants will receive mRNA-1020 at Dose Level B by IM injection on Day 1.
Participants will receive mRNA-1030 at Dose Level C by IM injection on Day 1.
Participants will receive mRNA-1020 at Dose Level C by IM injection on Day 1.
Participants will receive mRNA-1010 by IM injection on Day 1.
Participants will receive an active comparator by IM injection on Day 1.
Outcomes
Primary Outcome Measures
Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Number of Unsolicited Adverse Events (AEs)
Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Withdrawal
Change From Baseline in Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay
Change From Baseline in GMT of Anti-Neuraminidase (NA) Antibodies at Day 29, as Measured by Neuraminidase Inhibition (NAI) Assay
Change From Baseline in Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay
Change From Baseline in GMFR of Anti-NA Antibodies at Day 29, as Measured by NAI Assay
Percentage of Participants With Seroconversion, as Measured by HAI Assay
Seroconversion is defined as a Day 29 titer ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.
Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise
Secondary Outcome Measures
Change From Baseline in GMT of Anti-HA or Anti-NA Antibodies at Days 8, 29, and 181, as Measured by HAI, NAI, and/or Microneutralization (MN) Assays
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05333289
Brief Title
A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults
Official Title
Phase 1/2, Randomized, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1020 and mRNA-1030 Candidate Seasonal Influenza Vaccines in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 6, 2022 (Actual)
Primary Completion Date
November 22, 2022 (Actual)
Study Completion Date
November 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The primary objective of this study is to evaluate the safety, reactogenicity, and humoral immunogenicity of mRNA-1020, mRNA-1030, and mRNA-1010 vaccines against vaccine-matched influenza A and B strains.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Influenza
Keywords
Influenza vaccine, mRNA-1020, mRNA-1030, Moderna
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
572 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mRNA-1030 Dose Level A
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1030 at Dose Level A by intramuscular (IM) injection on Day 1.
Arm Title
mRNA-1020 Dose Level A
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1020 at Dose Level A by IM injection on Day 1.
Arm Title
mRNA-1030 Dose Level B
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1030 at Dose Level B by IM injection on Day 1.
Arm Title
mRNA-1020 Dose Level B
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1020 at Dose Level B by IM injection on Day 1.
Arm Title
mRNA-1030 Dose Level C
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1030 at Dose Level C by IM injection on Day 1.
Arm Title
mRNA-1020 Dose Level C
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1020 at Dose Level C by IM injection on Day 1.
Arm Title
mRNA-1010
Arm Type
Active Comparator
Arm Description
Participants will receive mRNA-1010 by IM injection on Day 1.
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
Participants will receive an active comparator by IM injection on Day 1.
Intervention Type
Biological
Intervention Name(s)
mRNA-1030
Other Intervention Name(s)
Seasonal influenza vaccine
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1020
Other Intervention Name(s)
Seasonal influenza vaccine
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1010
Other Intervention Name(s)
Seasonal influenza vaccine
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
Active Comparator
Other Intervention Name(s)
Seasonal influenza vaccine
Intervention Description
Sterile liquid for injection
Primary Outcome Measure Information:
Title
Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Time Frame
Up to Day 7 (7 days after vaccination)
Title
Number of Unsolicited Adverse Events (AEs)
Time Frame
Up to Day 28 (28 days after vaccination)
Title
Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Withdrawal
Time Frame
Day 1 through Day 181
Title
Change From Baseline in Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay
Time Frame
Baseline (Day 1), Day 29
Title
Change From Baseline in GMT of Anti-Neuraminidase (NA) Antibodies at Day 29, as Measured by Neuraminidase Inhibition (NAI) Assay
Time Frame
Baseline (Day 1), Day 29
Title
Change From Baseline in Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay
Time Frame
Baseline (Day 1), Day 29
Title
Change From Baseline in GMFR of Anti-NA Antibodies at Day 29, as Measured by NAI Assay
Time Frame
Baseline (Day 1), Day 29
Title
Percentage of Participants With Seroconversion, as Measured by HAI Assay
Description
Seroconversion is defined as a Day 29 titer ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.
Time Frame
Baseline (Day 1) to Day 29
Title
Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise
Time Frame
Baseline (Day 1) to Day 29
Secondary Outcome Measure Information:
Title
Change From Baseline in GMT of Anti-HA or Anti-NA Antibodies at Days 8, 29, and 181, as Measured by HAI, NAI, and/or Microneutralization (MN) Assays
Time Frame
Baseline (Day 1), Days 8, 29, and 181
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Body mass index of 18 kilograms (kg)/square meter (m^2) to 35 kg/m^2 (inclusive) at the Screening Visit.
For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 90 days following vaccine administration, and not currently breastfeeding.
Exclusion Criteria:
Participant has had close contact to someone with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) or has had a positive SARS-CoV-2 test in the past 10 days prior to the Screening Visit.
Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.
Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 180 days prior to screening (for corticosteroids ≥10 milligrams [mg]/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
Participant has received or plans to receive any licensed or authorized vaccine, including COVID-19 vaccines, ≤28 days prior to the study injection (Day 1) or plans to receive a licensed or authorized vaccine within 28 days after the study injection.
Participant has received a Northern Hemisphere (NH) 2021-2022 seasonal influenza vaccine or any other influenza vaccine within 180 days prior to Day 1.
Participant tested positive for influenza by CDC-recommended testing methods within 180 days prior to Day 1.
Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.
Note: Other inclusion/exclusion criteria may apply.
Facility Information:
Facility Name
Foothills Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85044
Country
United States
Facility Name
Alliance for MultiSpecialty Research
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Health Awareness, Inc.
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
IACT Health
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Meridian Clinical Research
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51106
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Sundance Clinical Research, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Meridian Clinical Research
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Lucas Research
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Trial Management Associates, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
Meridian Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Lynn Institute of Norman
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73072
Country
United States
Facility Name
LinQ Research, LLC
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
Olympus Family Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
South Ogden Family Medicine
City
South Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults
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