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

NCT05827068 | Completed Phase 1 Results FDA Drug

• 1 other identifier: mRNA-1011-P101
• Study Type: interventional
• Target: 698
• Locations: 1 country
• Sites: 22

Brief 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.

Conditions

Seasonal Influenza

Keywords

Influenza vaccine; mRNA-1010; mRNA-1011.1; mRNA-1011.2; mRNA-1012.1; Moderna

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)

  Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity.

  7 days post-vaccination

• Number of Participants With Unsolicited AEs

  An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Number of participants with unsolicited AEs (SAEs and non-serious AEs) up to 28 days post-vaccination are reported in this outcome measure.

  Up to 28 days post-vaccination

• Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation

  An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up) and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). Number of participants with SAEs, AESIs, MAAEs, and AEs leading to discontinuation up to the end of study (Day 181) are reported in this outcome measure.

  Day 1 to Day 181 (end of study [EOS])

Secondary Outcomes (3)

• Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains

  Day 29

• Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains

  Baseline, Day 29

• Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains

  Day 29

Study Arms (7)

mRNA-1011.1

EXPERIMENTAL

Participants will receive mRNA-1011.1 by intramuscular (IM) injection on Day 1.

Biological: mRNA-1011.1

mRNA-1011.2

EXPERIMENTAL

Participants will receive mRNA-1011.2 by IM injection on Day 1.

Biological: mRNA-1011.2

mRNA-1012.1 Dose Level A

EXPERIMENTAL

Participants will receive mRNA-1012.1 at dose level A by IM injection on Day 1.

Biological: mRNA-1012.1

mRNA-1012.1 Dose Level B

EXPERIMENTAL

Participants will receive mRNA-1012.1 at dose level B by IM injection on Day 1.

Biological: mRNA-1012.1

mRNA-1010

ACTIVE COMPARATOR

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

Biological: mRNA-1010

mRNA-1010.2

ACTIVE COMPARATOR

Participants will receive mRNA-1010.2 by IM injection on Day 1.

Biological: mRNA-1010.2

mRNA-1010.3

ACTIVE COMPARATOR

Participants will receive mRNA-1010.3 by IM injection on Day 1.

Biological: mRNA-1010.3

Interventions

mRNA-1011.1 BIOLOGICAL

Sterile liquid for injection

Also known as: Seasonal influenza vaccine

mRNA-1011.1

mRNA-1011.2 BIOLOGICAL

Sterile liquid for injection

Also known as: Seasonal influenza vaccine

mRNA-1011.2

mRNA-1012.1 BIOLOGICAL

Sterile liquid for injection

Also known as: Seasonal influenza vaccine

mRNA-1012.1 Dose Level A; mRNA-1012.1 Dose Level B

mRNA-1010 BIOLOGICAL

Sterile liquid for injection

Also known as: Seasonal influenza vaccine

mRNA-1010

mRNA-1010.2 BIOLOGICAL

Sterile liquid for injection

Also known as: Seasonal influenza vaccine

mRNA-1010.2

mRNA-1010.3 BIOLOGICAL

Sterile liquid for injection

Also known as: Seasonal influenza vaccine

mRNA-1010.3

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (22)

Long Beach Research Institute

Lakewood, California, 90805, United States

Location

Long Beach Clinical Trials

Long Beach, California, 90806, United States

Location

Tekton Research

Fort Collins, Colorado, 80528, United States

Location

Critical Care, Pulmonary and Sleep Associates / CCT Research

Lakewood, Colorado, 80228, United States

Location

CenExel RCA

Hollywood, Florida, 33024, United States

Location

Suncoast Research Associates, LLC

Miami, Florida, 33173, United States

Location

CenExel FCR

Tampa, Florida, 33613, United States

Location

Georgia Clinic / CCT Research

Norcross, Georgia, 30092, United States

Location

CenExel CBH

Gaithersburg, Maryland, 20877, United States

Location

DelRicht Research

Rockville, Maryland, 20852, United States

Location

DelRicht Research

Springfield, Missouri, 65807, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

DelRicht Research

Town and Country, Missouri, 63017, United States

Location

Meridian Clinical Research, LLC

Omaha, Nebraska, 68134, United States

Location

Healor Primary Care

Las Vegas, Nevada, 89102, United States

Location

Meridian Clinical Research, LLC

Vestal, New York, 13850, United States

Location

Tekton Research

Edmond, Oklahoma, 73013, United States

Location

Tekton Research

Moore, Oklahoma, 73160, United States

Location

The Corvallis Clinic, PC

Corvallis, Oregon, 97330, United States

Location

Hatboro Medical Associates / CCT Research

Hatboro, Pennsylvania, 19040, United States

Location

Trial Management Associates, LLC

Myrtle Beach, South Carolina, 29572, United States

Location

Springville Dermatology / CCT Research

Springville, Utah, 84663, United States

Location

Related Publications (1)

• Hsu D, Jayaraman A, Pucci A, Joshi R, Mancini K, Chen HL, Koslovsky K, Mao X, Choi A, Henry C, Vakil J, Stadlbauer D, Jorquera P, Arunkumar GA, Sanchez-Crespo NE, Wadsworth LT, Bhupathy V, Du E, Avanesov A, Ananworanich J, Nachbagauer R. Safety and immunogenicity of mRNA-based seasonal influenza vaccines formulated to include multiple A/H3N2 strains with or without the B/Yamagata strain in US adults aged 50-75 years: a phase 1/2, open-label, randomised trial. Lancet Infect Dis. 2025 Jan;25(1):25-35. doi: 10.1016/S1473-3099(24)00493-6. Epub 2024 Sep 5.

  PMID: 39245055 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

mRNA-1010 influenza vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Moderna Clinical Trials Support Center
• Organization: ModernaTX, Inc.

clinicaltrials@modernatx.com

1-877-777-7187

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 24, 2023
• Study Start: March 27, 2023
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Locations

US (22)