A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults

Phase 2, Open-Label Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 and Comparator Seasonal Influenza Vaccines in Healthy Adults

The main purpose of the study is to evaluate the safety, reactogenicity, and the humoral immunogenicity of mRNA-1010 and comparator influenza vaccines against homologous influenza A and B strains at Day 29.

Study Overview

• Status: Active, not recruiting
• Conditions: Influenza
• Intervention / Treatment: Biological: mRNA-1010; Biological: Egg-based Quadrivalent Influenza Vaccine; Biological: Adjuvanted Quadrivalent Influenza Vaccine; Biological: Inactivated Influenza Vaccine

Detailed Description

The study consists of two parts. Part A of the study was conducted for the 2022-23 influenza season. Part B of the study will be conducted in 2023-24 influenza season.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St. Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Part A only: Body mass index (BMI) of 18 kilograms (kg)/meter (m)^2 to < 40 kg/m^2 at the screening visit. There will be no BMI requirement for inclusion in Part B.
• Female participants of childbearing potential: has a negative pregnancy test on the day of vaccination (D1); practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days before D1; has agreed to continue adequate contraception through 3 months after vaccine administration; and is not currently breastfeeding.

Exclusion Criteria:

• Acutely ill or febrile (temperature ≥ 38.0°Celsius (C)/100.4° Fahrenheit (F) hours before or at the D1 vaccination visit. Participants meeting this criterion may be rescheduled within the 28-day screening window.
• 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.
• Reported history of congenital or acquired immunodeficiency, immunocompromising or immunosuppressive condition, asplenia, or history of recurrent severe infections. Certain immune-mediated conditions that are stable and well-controlled (for example, Hashimoto's thyroid disease) or that do not require systemic immunosuppressive therapy may be permitted at the discretion of the Investigator.
• Dermatologic conditions that could affect local solicited AR assessments (tattoos, psoriatic patches or vitiligo affecting skin over the deltoid injection site area).
• Has received systemic immunosuppressants (for glucocorticoids ≥ 10 mg/day of prednisone or equivalent) for > 14 days in total within 180 days before vaccination visit (D1) 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.
• Has received systemic immunoglobulins or long-acting biological therapies that may suppress or alter immune responses (for example, Infliximab®) or blood products within 90 days before the vaccination visit or plans to receive them during the study.
• Has a history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA or influenza vaccines or any components of the mRNA or influenza vaccines, including egg protein.

Other protocol-defined inclusion/exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mRNA-1010 (Age Group 18-50 years); Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.	Biological: mRNA-1010; Sterile liquid for injection
Active Comparator: Egg-based Quadrivalent Influenza Vaccine (Age Group 18-50 years); Participants will receive a single dose of egg-based quadrivalent influenza vaccine by IM injection on Day 1.	Biological: Egg-based Quadrivalent Influenza Vaccine; Sterile suspension for injection; Other Names: Fluarix®
Active Comparator: Adjuvanted Quadrivalent Influenza Vaccine (Age Group 65-80 years); Participants will receive a single dose of adjuvanted quadrivalent influenza vaccine by IM injection on Day 1.	Biological: Adjuvanted Quadrivalent Influenza Vaccine; Sterile injectable emulsion; Other Names: Fluad®
Active Comparator: Inactivated Influenza Vaccine (Age Group 65-80 years); Participants will receive a single dose of inactivated influenza vaccine by IM injection on Day 1.	Biological: Inactivated Influenza Vaccine; Sterile suspension for injection; Other Names: Fluzone®
Experimental: mRNA-1010 (Age Group 65-80 years); Participants will receive a single dose of mRNA-1010 by IM injection on Day 1.	Biological: mRNA-1010; Sterile liquid for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)		Up to Day 7 (7 days after vaccination)
Number of Unsolicited Adverse Events (AEs)		Up to Day 28 (28 days after vaccination)
Number of 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
Change from Baseline in Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutinin Inhibition (HAI) Assay		Baseline, Day 29
Change from Baseline in Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay		Baseline, Day 29
Percentage of Participants with Seroresponse, as Measured by HAI Assay	Seroresponse is defined as a Day 29 titer > 1:40 if baseline is < 1:10 or a minimum 4-fold rise if baseline is >1:10 in anti-HA antibodies measured by HAI assay.	Day 29

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in GMT of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or Microneutralization (MN) Assay	Baseline, Days 121 and 181
Change from Baseline in GMFR of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or MN Assay	Baseline, Days 121 and 181

Collaborators and Investigators

• Sponsor: ModernaTX, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2022
• Primary Completion (Estimated): August 9, 2024
• Study Completion (Estimated): August 9, 2024

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: October 31, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: March 1, 2024

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; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: mRNA-CRID-003

Drug and device information, study documents

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