A Study of Modified mRNA Vaccines in Healthy Adults
Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Modified mRNA Vaccines Using a Systems Biology Approach in Healthy Adults
1 other identifier
interventional
308
1 country
8
Brief Summary
The main goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of study vaccines.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2022
Typical duration for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 24, 2022
CompletedFirst Submitted
Initial submission to the registry
May 25, 2022
CompletedFirst Posted
Study publicly available on registry
May 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2026
CompletedMarch 12, 2026
March 1, 2026
3.8 years
May 25, 2022
March 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Up to Day 176 (7 days follow-up post-vaccination)
Number of Participants With Unsolicited Adverse Events (AEs)
Up to Day 197 (28 days follow-up post-vaccination)
Number of Participants With Serious AEs (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Study Withdrawal or Discontinuation of Study Vaccination
Day 1 through end of study (EOS) (up to Day 1249)
Number of Participants with Medically Attended Adverse Events (MAAEs)
Day 1 through Day 361
Secondary Outcomes (3)
Geometric Mean Titer (GMT) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345
Days 1 (Baseline), 29, 85, and 197
Geometric Mean Fold-Rise (GMFR) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345
Days 1 (Baseline), 29, 85, and 197
Percentage of Participants With Seroresponse for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, mRNA-1345, and mRNA-1647
Days 1 (Baseline), 29, 85, and 197
Study Arms (6)
Part 1: mRNA-1345
EXPERIMENTALParticipants will receive single intramuscular (IM) injection of mRNA-1345 on Day 1.
Part 1: mRNA-1647 2-Dose
EXPERIMENTALParticipants will receive single IM injection of mRNA-1647 on Days 1 and 57.
Part 1: mRNA-1647 3-Dose
EXPERIMENTALParticipants will receive single IM injection of mRNA-1647 on Days 1, 57, and 169.
Part 2: mRNA-1273
EXPERIMENTALParticipants will receive single IM injection of mRNA-1273 on Day 1
Part 2: mRNA-1010
EXPERIMENTALParticipants will receive single IM injection of mRNA-1010 on Day 1.
Part 2: FLUAD®
ACTIVE COMPARATORParticipants will receive single IM injection of FLUAD® on Day 1.
Interventions
adjuvanted (MF59), inactivated, quadrivalent seasonal influenza vaccine
Eligibility Criteria
You may qualify if:
- Adults 18 to 75 years of age at the time of consent (screening visit) who, in the opinion of the investigator, are in good health based on review of medical history and physical examination performed at screening. For mRNA-1647 study arms, adults 18 to \<50 years of age at the time of consent (screening visit) who, in the opinion of the investigator, are in good health based on review of medical history and physical examination performed at screening.
- Body mass index (BMI) of 18 kilograms (kg)/square meter (m\^2) to 35 kg/m\^2 (inclusive) at the screening visit.
You may not qualify if:
- Participant has had close contact to someone with confirmed SARS-CoV-2, respiratory syncytial virus (RSV), or influenza infection in the past 14 days prior to the screening visit.
- Severe allergic reaction to any component of the FLUAD vaccine (active comparator), including egg protein, or after a previous dose of any influenza vaccine.
- Participant has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to screening (to include any systemic corticosteroids) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
- Participant plans to receive any licensed or authorized vaccine, including COVID-19 influenza vaccines, within 28 days before or after any study injection.
- Participant has received a NH 2021 - 2022 or 2022-2023 seasonal influenza vaccine or any other influenza vaccine, or an experimental RSV or cytomegalovirus (CMV) vaccine, within 6 months prior to study Day 1, and/or has not completed a primary vaccination series for COVID-19.
- Participant has received an authorized or approved COVID-19 vaccine within 4 months prior to Day 1, and/or has not completed a primary vaccination series for COVID-19.
- Participant had a laboratory-confirmed infection with influenza or RSV within 6 months prior to Day 1, or SARS-CoV-2 within 4 months of Day 1. SARS-CoV-2 infection confirmed with self-administered, authorized or approved rapid antigen test is acceptable.
- Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the screening visit or plans to donate blood products during the study.
- Participated in an interventional clinical study within 28 days prior to the screening visit based on the medical history interview or plans to do so while participating in this study until 12 months after their last study vaccination.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ModernaTX, Inc.lead
Study Sites (8)
CenExel
Hollywood, Florida, 33024, United States
Meridian Clinical Research
Savannah, Georgia, 31406, United States
Meridian Clinical Research
Sioux City, Iowa, 51106, United States
Johnson County Clinical Trials
Lenexa, Kansas, 66219, United States
Meridian Clinical Research
Lincoln, Nebraska, 68510, United States
Benchmark Research
Austin, Texas, 78705, United States
Tekton Research, Inc
Austin, Texas, 78745, United States
DM Clinical Research- Texas Center for Drug Development
Houston, Texas, 77081, United States
Related Publications (3)
Henry C, Makrinos D, Liu R, Cavallaro M, Fenderson B, Sun Y, Chang X, Astley E, Girard B, Yu WH, Oostendorp J, DiPiazza A, Paris R. An mRNA influenza vaccine induces immunity comparable to an adjuvanted vaccine in a randomized trial. NPJ Vaccines. 2026 Jan 14;11(1):50. doi: 10.1038/s41541-026-01370-7.
PMID: 41535296DERIVEDKaplonek P, Vargas R, Lee JS, Bertera H, Astley E, Girard B, Oostendorp J, Henry C, Paris R, Yu WH, Alter G. mRNA-1010 influenza vaccine elicits distinct and enhanced humoral immunity compared to adjuvanted inactivated vaccines. NPJ Vaccines. 2025 Dec 15;11(1):19. doi: 10.1038/s41541-025-01340-5.
PMID: 41398408DERIVEDFierro C, Sanchez-Crespo N, Makrinos D, Zhang W, Sun Y, Rohilla P, Girard B, Adeniji A, DiPiazza A, Paris R. Shared clinical and immunologic features of mRNA vaccines: preliminary results from a comparative clinical study. Front Immunol. 2025 Apr 10;16:1501275. doi: 10.3389/fimmu.2025.1501275. eCollection 2025.
PMID: 40276503DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
May 25, 2022
First Posted
May 31, 2022
Study Start
May 24, 2022
Primary Completion
February 27, 2026
Study Completion
February 27, 2026
Last Updated
March 12, 2026
Record last verified: 2026-03