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

NCT05606965 | Completed Phase 2 FDA Drug

• 1 other identifier: mRNA-CRID-003
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Influenza

Keywords

mRNA-1010; Influenza Vaccine; Moderna

Outcome Measures

Primary Outcomes (9)

• Parts A, B, and C: Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

  Up to Day 7 (7 days after vaccination)

• Parts A, B, and C: Number of Unsolicited Adverse Events (AEs)

  Up to Day 28 (28 days after vaccination)

• Parts A, B, and C: 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

• Parts A, B, and C: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutinin Inhibition (HAI) Assay

  Day 29

• Part C: GMT of Anti-Respiratory Syncytial Virus (RSV) Antibodies at Day 29, as Measured by Microneutralization Assay for RSV A and B

  Day 29

• Parts A, B, and C: Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay

  Baseline, Day 29

• Part C: GMFR of Anti-RSV Antibodies at Day 29, as Measured by Microneutralization Assay

  Baseline, Day 29

• Parts A, B, and C: Percentage of Participants with Seroresponse at Day 29, 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

• Part C: Percentage of Participants with Seroresponse at Day 29, as Measured by RSV Neutralization Assay

  Seroresponse is defined as post-baseline titer ≥4-fold if baseline is ≥LLOQ or ≥4×LLOQ if baseline titer is \<LLOQ in neutralizing antibody titers measured by RSV neutralization assay, at Day 29.

  Day 29

Secondary Outcomes (6)

• Parts A and B: GMT of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or Microneutralization Assay

  Days 121 and 181

• Part C: GMT of Anti-HA Antibodies at Days 57, 121, and 181, as Measured by HAI Assay or Microneutralization Assay

  Days 57, 121, and 181

• Parts A and B: GMFR of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or MN Assay

  Baseline, Days 121 and 181

• Part C: GMFR of Anti-HA Antibodies at Days 57, 121, and 181, as Measured by HAI Assay or MN Assay

  Baseline, Days 57, 121, and 181

• Part C: Percentage of Participants with Seroresponse at Days 57, 121, and 181, as Measured by HAI Assay

  Days 57, 121, and 181

Study Arms (8)

Parts A and B - Arm 1: mRNA-1010 (Age Group 18-50 years)

EXPERIMENTAL

Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.

Biological: mRNA-1010

Parts A and B - Arm 2: Egg-based Quadrivalent Influenza Vaccine (Age Group 18-50 years)

ACTIVE COMPARATOR

Participants will receive a single dose of egg-based quadrivalent influenza vaccine by IM injection on Day 1.

Biological: Egg-based Quadrivalent Influenza Vaccine

Parts A and B - Arm 3: Adjuvanted Quadrivalent Influenza Vaccine (Age Group 65-80 years)

ACTIVE COMPARATOR

Participants will receive a single dose of adjuvanted quadrivalent influenza vaccine by IM injection on Day 1.

Biological: Adjuvanted Quadrivalent Influenza Vaccine

Parts A and B - Arm 4: Inactivated Influenza Vaccine (Age Group 65-80 years)

ACTIVE COMPARATOR

Participants will receive a single dose of inactivated influenza vaccine by IM injection on Day 1.

Biological: Inactivated Influenza Vaccine

Parts A and B - Arm 5: mRNA-1010 (Age Group 65-80 years)

EXPERIMENTAL

Participants will receive a single dose of mRNA-1010 by IM injection on Day 1.

Biological: mRNA-1010

Part C - Arm 1: mRNA-1010 and mRNA-1345 (Age Group 18-50 years)

EXPERIMENTAL

Participants will receive one dose of mRNA-1010 concomitantly injected with one dose of mRNA-1345 in the contralateral arm at Day 1.

Biological: mRNA-1010; Biological: mRNA-1345

Part C - Arm 2: mRNA-1010 and mRNA-1345 (Age Group 18-50 years)

EXPERIMENTAL

Participants will receive one dose of mRNA-1010 at Day 1 followed by one dose of mRNA-1345 in the contralateral arm at Day 29.

Biological: mRNA-1010; Biological: mRNA-1345

Part C - Arm 3: mRNA-1045 (Age Group 18-50 years)

EXPERIMENTAL

Participants will receive a single dose of mRNA-1045 by IM injection on Day 1.

Biological: mRNA-1045

Interventions

mRNA-1010 BIOLOGICAL

Sterile liquid for injection

Part C - Arm 1: mRNA-1010 and mRNA-1345 (Age Group 18-50 years); Part C - Arm 2: mRNA-1010 and mRNA-1345 (Age Group 18-50 years); Parts A and B - Arm 1: mRNA-1010 (Age Group 18-50 years); Parts A and B - Arm 5: mRNA-1010 (Age Group 65-80 years)

Egg-based Quadrivalent Influenza Vaccine BIOLOGICAL

Sterile suspension for injection

Also known as: Fluarix®

Parts A and B - Arm 2: Egg-based Quadrivalent Influenza Vaccine (Age Group 18-50 years)

Adjuvanted Quadrivalent Influenza Vaccine BIOLOGICAL

Sterile injectable emulsion

Also known as: Fluad®

Parts A and B - Arm 3: Adjuvanted Quadrivalent Influenza Vaccine (Age Group 65-80 years)

Inactivated Influenza Vaccine BIOLOGICAL

Sterile suspension for injection

Also known as: Fluzone®

Parts A and B - Arm 4: Inactivated Influenza Vaccine (Age Group 65-80 years)

mRNA-1345 BIOLOGICAL

Sterile liquid for injection

Part C - Arm 1: mRNA-1010 and mRNA-1345 (Age Group 18-50 years); Part C - Arm 2: mRNA-1010 and mRNA-1345 (Age Group 18-50 years)

mRNA-1045 BIOLOGICAL

Sterile liquid for injection

Part C - Arm 3: mRNA-1045 (Age Group 18-50 years)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18-50 years (Study Parts A, B, and C) and 65-80 years (Study Parts A and B only) of age at the time of consent (Screening Visit).
• A person of childbearing potential (POCBP): has a negative highly sensitive pregnancy test at the Screening Visit and before each administration of study intervention; must use a contraceptive method that is highly effective from at least 28 days prior to Day 1 (Baseline) to at least 3 months after the last study intervention; and is not currently pregnant or breastfeeding.

You may not qualify if:

• 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, immunocompromizing 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

mRNA-1010 influenza vaccine; fluarix; fluad vaccine; Influenza Vaccines; mRNA-1345 respiratory syncytial virus vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study design for Part A and Prt C is randomized and Part B is non-randomized.

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 7, 2022
• Study Start: November 2, 2022
• Primary Completion: November 13, 2025
• Study Completion: November 13, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

US (1)