A Study of Modified mRNA Vaccines in Healthy Adults
- Summary
- The main goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of study vaccines.
- Short title
- A Study of Modified mRNA Vaccines in Healthy Adults
- Official title
- Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Modified mRNA Vaccines Using a Systems Biology Approach in Healthy Adults
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-02-27
- First posted
- 2022-05-31
- Registry last updated
- 2026-03-12
- Primary completion date
- 2026-02-27
- Start date
- 2022-05-24
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- ModernaTX, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05397223
- ClinicalTrials.gov ID
- NCT05397223
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- No masking
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Timeframe: Up to Day 176 (7 days follow-up post-vaccination)
Number of Participants With Unsolicited Adverse Events (AEs)
Timeframe: 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
Timeframe: Day 1 through end of study (EOS) (up to Day 1249)
Number of Participants with Medically Attended Adverse Events (MAAEs)
Timeframe: Day 1 through Day 361
Geometric Mean Titer (GMT) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345
Timeframe: 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
Timeframe: 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
Timeframe: Days 1 (Baseline), 29, 85, and 197
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- Yes
- 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.
- 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.
Other inclusion and exclusion criteria may apply.
- CenExelHollywood, United States
- Meridian Clinical ResearchSavannah, United States
- Meridian Clinical ResearchSioux City, United States
- Johnson County Clinical TrialsLenexa, United States
- Meridian Clinical ResearchLincoln, United States
- Benchmark ResearchAustin, United States
- Tekton Research, IncAustin, United States
- DM Clinical Research- Texas Center for Drug DevelopmentHouston, United States
- PubMed 41535296Related publication
- PubMed 41398408Related publication
- PubMed 40276503Related publication
Related records
Drugs (1)
Lead sponsors (1)
Conditions (3)
- COVID-19 Primary condition
- Cytomegalovirus infection
- Influenza