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A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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

NCT05333289•ModernaTX, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (15)

Foothills Research Center

Phoenix, Arizona, United States

Alliance for MultiSpecialty Research

Coral Gables, Florida, United States

Health Awareness, Inc.

Jupiter, Florida, United States

IACT Health

Columbus, Georgia, United States

Meridian Clinical Research

Sioux City, Iowa, United States

Heartland Research Associates, LLC

Wichita, Kansas, United States

Sundance Clinical Research, LLC

St Louis, Missouri, United States

Meridian Clinical Research

Endwell, New York, United States

Lucas Research

Morehead City, North Carolina, United States

Trial Management Associates, LLC

Wilmington, North Carolina, United States

Key Dates

Start Date

April 6, 2022

Primary Completion Date

November 22, 2022

Completion Date

November 22, 2022

Last Updated

February 1, 2024

Enrollment

572

ACTUAL participants

Conditions

Seasonal Influenza

Interventions

mRNA-1030

BIOLOGICAL

mRNA-1020

BIOLOGICAL

mRNA-1010

BIOLOGICAL

Active Comparator

BIOLOGICAL

A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age

NCT06602024

Seasonal Influenza

View study

COMPLETEDPHASE3

Study of mRNA-1010 Seasonal Influenza Vaccine in Adults

NCT05827978

Seasonal Influenza

View study

COMPLETEDPHASE1/PHASE2

A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults

NCT05827068

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age

Study of mRNA-1010 Seasonal Influenza Vaccine in Adults

A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults

Lot-to-lot Consistency of Quadrivalent Influenza Vaccine (Split Virion), Inactivated

Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010

Yearly Strain Variation Study, 2009/2010