Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults

A Phase 2, Randomized, Active-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults 18 to 49 Years of Age

The main purpose of the study is to evaluate the safety, reactogenicity, and the immunogenicity of mRNA-1010 vaccine candidate variations.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: mRNA-1010; Biological: mRNA-1010.4; Biological: mRNA-1010.6

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Hollywood, Florida, United States, 33024
      • Cenexel RCA
    • Miami, Florida, United States, 33135
      • Suncoast Research Group
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Johnson County Clin-Trials
  • Maryland
    • Rockville, Maryland, United States, 20854
      • Rockville Internal Medicine
  • Michigan
    • Southfield, Michigan, United States, 48076
      • DM Clinical Research
  • Nebraska
    • Hastings, Nebraska, United States, 68901
      • Meridian Clinical Research
    • Lincoln, Nebraska, United States, 68510
      • Meridian Clinical Research
  • New York
    • Binghamton, New York, United States, 13905
      • United Medical Associates
  • Texas
    • Sugar Land, Texas, United States, 77478
      • DM Clinical Research
    • Tomball, Texas, United States, 77375
      • Texas Center for Drug Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Investigator has assessed that the participant understands and is willing and physically able to comply with protocol mandated follow up, including all procedures.
• For assigned females at birth and 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, and agreement to continue adequate contraception through 90 days following vaccine administration.

Exclusion Criteria:

• Participant has had close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®) within the past 5 days prior to Day 1.
• Participant is acutely ill or febrile (temperature ≥38.0℃elcius [100.4°Fahrenheit]) 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.
• Participant has a history of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
• Reported history of congenital or acquired immunodeficiency, immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections.
• Participant has tested positive for influenza by local health authority-approved testing methods within 150 days prior to Day 1.
• Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of mRNA vaccines or any components of the mRNA-1010 or influenza vaccines, including egg protein.
• Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Day 1 (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. Inhaled, nasal and topical steroids are allowed. Intra-articular and epidural steroid injections are not allowed within 28 days before and/or after study intervention dosing.
• Participant has received any vaccine authorized or approved by local health agency ≤28 days prior to study intervention dosing (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after study intervention dosing.
• Participant has received a licensed seasonal influenza vaccine within 5 months (150 days) prior to Day 1.
• Participant has participated in any investigational seasonal influenza vaccine study within12 months prior to Day 1.
• Participant is not aware whether they have received an influenza vaccine in the prior 12 months.
• Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to Day 1 or plans to donate blood products during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mRNA-1010 Dose C; Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.	Biological: mRNA-1010; Sterile liquid for injection
Experimental: mRNA-1010.4 Dose B; Participants will receive a single dose of mRNA-1010.4 by IM injection on Day 1.	Biological: mRNA-1010.4; Sterile liquid for injection
Experimental: mRNA-1010.4 Dose C; Participants will receive a single dose of mRNA-1010.4 by IM injection on Day 1.	Biological: mRNA-1010.4; Sterile liquid for injection
Experimental: mRNA-1010.6 Dose A; Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1.	Biological: mRNA-1010.6; Sterile liquid for injection
Experimental: mRNA-1010.6 Dose B; Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1.	Biological: mRNA-1010.6; Sterile liquid for injection
Experimental: mRNA-1010.6 Dose C; Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1.	Biological: mRNA-1010.6; Sterile liquid for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.	7 days post-vaccination
Number of Participants With Unsolicited Adverse Events (AEs)	An unsolicited AE was an AE that was not solicited using a participant diary and that was communicated by a participant who has signed the informed consent. 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 Study or Treatment 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/or coronavirus disease 2019 [COVID-19] 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains	Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. 95% CI was calculated based on the t-distribution of log-transformed values for GM titer, then back transformed to original scale for presentation.	Days 1 (Baseline), 8, 29, 91, and 181
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains	The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% confidence interval (CI) for GMFR was calculated based on the t distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.	Baseline, Days 8, 29, 91, and 181
Percentage of Participants With Seroresponse for mRNA-1010, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains	Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroresponse was defined as (a) a post-vaccination antibody titer ≥ 4 * lower limit of quantification (LLOQ) if baseline (Day 1) antibody titer was < LLOQ or (b) a post-vaccination antibody titer ≥ 4-fold of baseline antibody titer if baseline antibody titer was ≥ LLOQ.	Days 8, 29, 91, and 181

Collaborators and Investigators

• Sponsor: ModernaTX, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Actual): December 19, 2023
• Study Completion (Actual): December 19, 2023

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Moderna; mRNA-1010; Influenza Vaccine
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human
• Other Study ID Numbers: mRNA-CRID-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No