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A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

A Phase 1/2, Randomized, Open-Label Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults 50 to 75 Years of Age

NCT05827068•ModernaTX, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to measure the safety and the immune response to 3 next-generation influenza vaccine candidates (mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1) compared with influenza vaccine candidate mRNA-1010 controls in healthy adult participants.

Eligibility

Age

50 - 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 3 months following vaccine administration, and not currently breastfeeding.

Exclusion Criteria

•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 for \>14 days in total within 180 days prior to the Randomization Visit (for glucocorticosteroids ≥10 milligrams \[mg\]/day of prednisone equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed.
•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 seasonal influenza vaccine or any other influenza vaccine within 180 days prior to the Randomization Visit.
•Participant tested positive for influenza by local health authority-approved testing methods within 180 days prior to the Randomization Visit.
•Participant has had close contact to someone with or been diagnosed themselves with respiratory syncytial virus or SARS-CoV-2 infection as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 days prior to the Randomization Visit.
•Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Randomization Visit or plans to donate blood products during the study.

Locations (22)

Long Beach Research Institute

Lakewood, California, United States

Long Beach Clinical Trials

Long Beach, California, United States

Tekton Research

Fort Collins, Colorado, United States

Critical Care, Pulmonary and Sleep Associates / CCT Research

Lakewood, Colorado, United States

CenExel RCA

Hollywood, Florida, United States

Suncoast Research Associates, LLC

Miami, Florida, United States

CenExel FCR

Tampa, Florida, United States

Georgia Clinic / CCT Research

Norcross, Georgia, United States

CenExel CBH

Gaithersburg, Maryland, United States

DelRicht Research

Rockville, Maryland, United States

Key Dates

Start Date

March 27, 2023

Primary Completion Date

November 20, 2023

Completion Date

November 20, 2023

Last Updated

February 3, 2025

Enrollment

698

ACTUAL participants

Conditions

Seasonal Influenza

Interventions

mRNA-1011.1

BIOLOGICAL

mRNA-1011.2

BIOLOGICAL

mRNA-1012.1

BIOLOGICAL

mRNA-1010

BIOLOGICAL

mRNA-1010.2

BIOLOGICAL

mRNA-1010.3

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-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults

NCT05333289

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 3, 2025Data 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-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate 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-1020 and mRNA-1030 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