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	Time Frame
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)	Up to Day 7 (7 days after vaccination)
Number of Participants with Unsolicited Adverse Events (AEs)	Up to Day 29 (28 days after vaccination)
Number of Participants with Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation	Day 1 through Day 181

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Geometric Mean Titer (GMT), as Measured by Hemagglutinin Inhibition (HAI) Assay		Baseline, Day 181
Change from Baseline in Geometric Mean Fold Rise (GMFR) of Postinjection/Baseline, as Measured by HAI Assay		Baseline, Day 181
Percentage of Participants with Seroresponse for mRNA-1010, as Measured by HAI Assay	Seroresponse is defined as an increase of antibody titers and concentrations from predose below the prespecified lower limit of quantification.	Day 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 (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Moderna; mRNA-1010; Influenza Vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; 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