A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Seasonal Influenza

Intervention / Treatment
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* Biological: mRNA-1030
* Biological: mRNA-1020
* Biological: mRNA-1010
* Biological: Active Comparator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mRNA-1030 Dose Level A<br>Participants will receive mRNA-1030 at Dose Level A by intramuscular (IM) injection on Day 1. | Biological: mRNA-1030<br>* Sterile liquid for injection<br>* Other names: Seasonal influenza vaccine;|
| Experimental: mRNA-1020 Dose Level A<br>Participants will receive mRNA-1020 at Dose Level A by IM injection on Day 1. | Biological: mRNA-1020<br>* Sterile liquid for injection<br>* Other names: Seasonal influenza vaccine;|
| Experimental: mRNA-1030 Dose Level B<br>Participants will receive mRNA-1030 at Dose Level B by IM injection on Day 1. | Biological: mRNA-1030<br>* Sterile liquid for injection<br>* Other names: Seasonal influenza vaccine;|
| Experimental: mRNA-1020 Dose Level B<br>Participants will receive mRNA-1020 at Dose Level B by IM injection on Day 1. | Biological: mRNA-1020<br>* Sterile liquid for injection<br>* Other names: Seasonal influenza vaccine;|
| Experimental: mRNA-1030 Dose Level C<br>Participants will receive mRNA-1030 at Dose Level C by IM injection on Day 1. | Biological: mRNA-1030<br>* Sterile liquid for injection<br>* Other names: Seasonal influenza vaccine;|
| Experimental: mRNA-1020 Dose Level C<br>Participants will receive mRNA-1020 at Dose Level C by IM injection on Day 1. | Biological: mRNA-1020<br>* Sterile liquid for injection<br>* Other names: Seasonal influenza vaccine;|
| Active Comparator: mRNA-1010<br>Participants will receive mRNA-1010 by IM injection on Day 1. | Biological: mRNA-1010<br>* Sterile liquid for injection<br>* Other names: Seasonal influenza vaccine;|
| Active Comparator: Active Comparator<br>Participants will receive an active comparator by IM injection on Day 1. | Biological: Active Comparator<br>* Sterile liquid for injection<br>* Other names: Seasonal influenza vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) |  | Up to Day 7 (7 days after vaccination) | 
| Number of Unsolicited Adverse Events (AEs) |  | Up to Day 28 (28 days after vaccination) | 
| Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Withdrawal |  | Day 1 through Day 181 | 
| Change From Baseline in Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay |  | Baseline (Day 1), Day 29 | 
| Change From Baseline in GMT of Anti-Neuraminidase (NA) Antibodies at Day 29, as Measured by Neuraminidase Inhibition (NAI) Assay |  | Baseline (Day 1), Day 29 | 
| Change From Baseline in Geometric Mean Fold-Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay |  | Baseline (Day 1), Day 29 | 
| Change From Baseline in GMFR of Anti-NA Antibodies at Day 29, as Measured by NAI Assay |  | Baseline (Day 1), Day 29 | 
| 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. | Baseline (Day 1) to Day 29 | 
| Percentage of Participants With a Change in the Day 29 Titer of at Least 2-/3-/4-Fold Rise |  | Baseline (Day 1) to Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Baseline (Day 1), Days 8, 29, and 181 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza vaccine, mRNA-1020, mRNA-1030, Moderna