A Study of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults

NCT ID: NCT04956575

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 885 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-06
• Study Completion Date: 2022-09-27

Brief Summary

The study comprises 3 parts: Phase 1/2, Phase 2 Northern Hemisphere (NH), and Phase 2 extension. The primary objective of this study is to evaluate the safety, reactogenicity, and humoral immunogenicity of mRNA-1010 vaccine.

Conditions

Seasonal Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Phase 1/2: mRNA-1010 Dose Level A

Participants will receive mRNA-1010 at dose level A by intramuscular (IM) injection on Day 1.

Group Type: EXPERIMENTAL

mRNA-1010

Intervention Type: BIOLOGICAL

Sterile liquid for injection

Phase 1/2: mRNA-1010 Dose Level B

Participants will receive mRNA-1010 at dose level B by IM injection on Day 1.

Group Type: EXPERIMENTAL

mRNA-1010

Intervention Type: BIOLOGICAL

Sterile liquid for injection

Phase 1/2: mRNA-1010 Dose Level C

Participants will receive mRNA-1010 at dose level C by IM injection on Day 1.

Group Type: EXPERIMENTAL

mRNA-1010

Intervention Type: BIOLOGICAL

Sterile liquid for injection

Phase 1/2: Placebo

Participants will receive placebo matching to mRNA-1010 by IM injection on Day 1.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: BIOLOGICAL

0.9% sodium chloride solution for injection

Phase 2 NH: Active Comparator Dose Level A

Participants will receive active comparator at dose level A by IM injection on Day 1.

Group Type: ACTIVE_COMPARATOR

Active Comparator

Intervention Type: BIOLOGICAL

0.5 milliliter (mL) intramuscular (IM) injection

Phase 2 NH: mRNA-1010 Dose Level D

Participants will receive mRNA-1010 at dose level D by IM injection on Day 1.

Group Type: EXPERIMENTAL

mRNA-1010

Intervention Type: BIOLOGICAL

Sterile liquid for injection

Phase 2 NH: mRNA-1010 Dose Level A

Participants will receive mRNA-1010 at dose level A by IM injection on Day 1.

Group Type: EXPERIMENTAL

mRNA-1010

Intervention Type: BIOLOGICAL

Sterile liquid for injection

Phase 2 NH: mRNA-1010 Dose Level B

Participants will receive mRNA-1010 at dose level B by IM injection on Day 1.

Group Type: EXPERIMENTAL

mRNA-1010

Intervention Type: BIOLOGICAL

Sterile liquid for injection

Phase 2 Extension: Active Comparator Dose Level A

Participants will receive active comparator at dose level A by IM injection on Day 1.

Group Type: ACTIVE_COMPARATOR

Active Comparator

Intervention Type: BIOLOGICAL

0.5 milliliter (mL) intramuscular (IM) injection

Phase 2 Extension: mRNA-1010 Dose Level D

Participants will receive mRNA-1010 at dose level D by IM injection on Day 1.

Group Type: EXPERIMENTAL

mRNA-1010

Intervention Type: BIOLOGICAL

Sterile liquid for injection

Phase 2 Extension: mRNA-1010 Dose Level E

Participants will receive mRNA-1010 at dose level E by IM injection on Day 1.

Group Type: EXPERIMENTAL

mRNA-1010

Intervention Type: BIOLOGICAL

Sterile liquid for injection

Phase 2 Extension: mRNA-1010 Dose Level F

Participants will receive mRNA-1010 at dose level F by IM injection on Day 1.

Group Type: EXPERIMENTAL

mRNA-1010

Intervention Type: BIOLOGICAL

Sterile liquid for injection

Interventions

mRNA-1010

Sterile liquid for injection

Intervention Type: BIOLOGICAL

Placebo

0.9% sodium chloride solution for injection

Intervention Type: BIOLOGICAL

Active Comparator

0.5 milliliter (mL) intramuscular (IM) injection

Intervention Type: BIOLOGICAL

Other Intervention Names

Seasonal influenza vaccine; Licensed quadrivalent seasonal influenza

Eligibility Criteria

Inclusion Criteria

Phase 1/2:

• Participant has a body mass index (BMI) of 18 kilograms (kg)/square meter (m^2) to 35 kg/m^2 (inclusive) at the Screening Visit.
• Participant is in good health, in the opinion of the Investigator, based on review of medical history and physical examination performed at screening.
• 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 3 months following vaccine administration, and not currently breastfeeding.

Phase 2 NH and Phase 2 Extension:

• Participant is medically stable, in the opinion of the Investigator, based on review of medical history and physical examination performed at screening.
• 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 3 months following vaccine administration, and not currently breastfeeding.

Exclusion Criteria

Phase 1/2:

• Participant has had significant exposure to someone with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, COVID-19, or influenza-like illness (ILI) in the past 14 days prior to the Screening Visit, as defined by the United States Centers for Disease Control and Prevention (CDC) as close contact with someone who has COVID-19.
• Participant has a positive SARS-CoV-2 reverse transcriptase polymerase chain reaction (RT-PCR) or antigen test in the past 10 days prior to the Screening Visit.
• Participant is acutely ill or febrile (body temperature ≥ 38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.
• Participant has a pre-existing medical condition that is not stable, at the discretion of the Investigator.
• Participant has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment.
• Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening Visit (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 vaccine ≤28 days prior to the investigational product (IP) injection (Day 1) or plans to receive a licensed vaccine within 28 days after the IP injection, with the exception of vaccines authorized or approved for the prevention of COVID-19 (regardless of type of vaccine) that become available to participants during the study. Efforts should be made to space study vaccination and COVID-19 vaccination by at least 7 and preferably 14 days, but COVID-19 vaccination should not be delayed.
• Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine after 01 January 2021.

Phase 2 NH:

• Participant has had close contact to someone with SARS-CoV-2 infection or COVID-19 as defined by the CDC (CDC 2021a) in the past 14 days prior to the Screening Visit, unless the participant has been fully vaccinated for COVID-19.
• Participant is acutely ill or febrile (body temperature ≥ 38.0°C/100.4°F) 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window and will retain their initially assigned participant number.
• Participant has a medical, psychiatric, occupational condition, or history of substance abuse that may pose additional risk as a result of participation or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment.
• Participant has a current or previous diagnosis of immunocompromising/immunosuppressive condition, immune mediated disease requiring immune-modifying therapy, asplenia, recurrent severe infections (human immunodeficiency virus [HIV] positive participants on antiretroviral therapy with cluster of differentiation [CD] 4 count ≥ 350 cells/mm3 and HIV RNA ≤ 500 copies/mL within the past 12 months are permitted).
• Participant has received systemic immunosuppressants or immune-modifying drugs for > 14 days in total within 6 months prior to Screening Visit (for corticosteroids ≥ 10 mg/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study.
• Participant has a history of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine or any of the components contained in the mRNA 1010 or the comparator vaccine, which is an egg-based influenza vaccine.
• Participant has received or plans to receive any licensed vaccine ≤ 28 days prior to the IP injection (Day 1) or plans to receive a licensed vaccine within 28 days after the IP injection, with the exception of vaccines authorized or approved for the prevention of COVID-19 (regardless of type of vaccine) that become available to participants during the study. Efforts should be made to space study vaccination and COVID-19 vaccination by at least 7 and preferably 14 days, but COVID-19 vaccination should not be delayed.
• Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 6 months prior to the Screening Visit.
• Participant has tested positive for influenza by CDC-recommended testing methods within 6 months prior to the Screening Visit.
• Participant has participated in an interventional clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study.

Phase 2 Extension:

• Participant has had close contact to someone with SARS-CoV-2 infection or COVID-19 as defined by the CDC in the past 10 days prior to the Screening Visit.
• Participant is acutely ill or febrile (body temperature ≥ 38.0°C/100.4°F) 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window and will retain their initially assigned participant number.
• Participant has a medical, psychiatric, occupational condition, or history of substance abuse that may pose additional risk as a result of participation or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment.
• Participant has a current or previous diagnosis of immunocompromising/immunosuppressive condition, immune-mediated disease requiring immune-modifying therapy, asplenia, recurrent severe infections (HIV-positive participants on antiretroviral therapy with CD 4 count ≥ 350 cells/mm^3 and HIV-RNA ≤ 500 copies/mL within the past 365 days are permitted).
• Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 180 days prior to Screening Visit (for corticosteroids ≥ 10 mg/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study.
• Participant has a history of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine or any of the components contained in the mRNA-1010 or the comparator vaccine, which is an egg-based influenza vaccine.
• Participant has received or plans to receive any licensed vaccine ≤ 28 days prior to the IP injection (Day 1) or plans to receive a licensed vaccine within 28 days after the IP injection, with the exception of vaccines authorized or approved for the prevention of COVID-19 (regardless of type of vaccine) that become available to participants during the study. Efforts should be made to space study vaccination and COVID-19 vaccination by at least 7 and preferably 14 days, but COVID-19 vaccination should not be delayed.
• Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 180 days prior to the randomization visit.
• Participant had tested positive for influenza by CDC-recommended testing methods within 180 days prior to the Screening Visit.
• Participant has participated in an interventional clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ModernaTX, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cognitive Clinical Trials - Phoenix

Phoenix, Arizona, United States

Alliance for Multispecialty Research, LLC - Phoenix

Tempe, Arizona, United States

Benchmark Research - Colton, CA

Colton, California, United States

Research Centers of America - ERGG - PPDS

Hollywood, Florida, United States

Meridian Clinical Research (Savannah Georgia) - Platinum - PPDS

Savannah, Georgia, United States

Meridian Clinical Research

Sioux City, Iowa, United States

Johnson County Clin-Trials

Lenexa, Kansas, United States

Meridian Clinical Research - Baton Rouge

Baton Rouge, Louisiana, United States

Meridian Clinical Research

Rockville, Maryland, United States

Meridian Clinical Research (Grand Island)

Grand Island, Nebraska, United States

Meridian Clinical Research, LLC (Lincoln Nebraska)

Lincoln, Nebraska, United States

Meridian Clinical Research

Omaha, Nebraska, United States

Meridian Clinical Research (Endwell-New York) - Platinum - PPDS

Endwell, New York, United States

Lucas Research

Morehead City, North Carolina, United States

Trial Management Associates LLC - ERN - PPDS

Wilmington, North Carolina, United States

Meridian Clinical Research - Cincinnati - Platinum - PPDS

Cincinnati, Ohio, United States

Meridian Clinical Research - Cincinnati - Platinum - PPDS

Cincinnati, Ohio, United States

Keystone VitaLink Research - Greenville - PPDS

Greenville, South Carolina, United States

PanAmerican Clinical Research LLC

Brownsville, Texas, United States

Research Your Health - ERN - PPDS

Plano, Texas, United States

South Ogden Family Medicine/Ogden Clinic - CCT

South Ogden, Utah, United States

Countries

United States

References

Lee IT, Nachbagauer R, Ensz D, Schwartz H, Carmona L, Schaefers K, Avanesov A, Stadlbauer D, Henry C, Chen R, Huang W, Schrempp DR, Ananworanich J, Paris R. Safety and immunogenicity of a phase 1/2 randomized clinical trial of a quadrivalent, mRNA-based seasonal influenza vaccine (mRNA-1010) in healthy adults: interim analysis. Nat Commun. 2023 Jun 19;14(1):3631. doi: 10.1038/s41467-023-39376-7.

Reference Type: RESULT

PMID: 37336877 (View on PubMed)

Ananworanich J, Lee IT, Ensz D, Carmona L, Schaefers K, Avanesov A, Stadlbauer D, Choi A, Pucci A, McGrath S, Kuo HH, Henry C, Chen R, Huang W, Nachbagauer R, Paris R. Safety and Immunogenicity of mRNA-1010, an Investigational Seasonal Influenza Vaccine, in Healthy Adults: Final Results From a Phase 1/2 Randomized Trial. J Infect Dis. 2025 Feb 4;231(1):e113-e122. doi: 10.1093/infdis/jiae329.

Reference Type: DERIVED

PMID: 38934845 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

mRNA-1010-P101

Identifier Type: -

Identifier Source: org_study_id