mRNA Vaccine for COVID-19 and Flu
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on corticosteroids or systemic immunosuppressive treatments, you may need to stop or adjust them as per the trial's exclusion criteria.
What data supports the effectiveness of the mRNA-1083 treatment for COVID-19 and flu?
Research on similar mRNA vaccines, like mRNA-1273, shows they can create strong immune responses and protect against COVID-19. A combined mRNA vaccine for COVID-19 and flu has been shown to produce protective antibodies and immune responses in mice, suggesting potential effectiveness for mRNA-1083.12345
Is the mRNA vaccine for COVID-19 and Flu generally safe for humans?
The mRNA vaccines, like those developed for COVID-19, have been shown to be generally safe in humans. Some people may experience mild side effects like chills, muscle aches, and fatigue, and there is a small risk of rare heart-related issues. Overall, these vaccines are well-tolerated and have a lower risk of serious side effects compared to traditional flu vaccines.678910
How is the mRNA-1083 treatment different from other treatments for COVID-19 and flu?
The mRNA-1083 treatment is unique because it combines mRNA vaccines for both COVID-19 and influenza into a single shot, potentially offering protection against both viruses simultaneously. This combined approach could simplify vaccination schedules and improve convenience compared to receiving separate vaccines for each virus.511121314
What is the purpose of this trial?
The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity in relation to the product attributes of mRNA-1083 vaccine when administered as a single intramuscular (IM) injection in adults ≥50 to \<65 years of age.
Eligibility Criteria
This clinical trial is for adults aged between 50 and 65 who are in good health. The study aims to test a new vaccine targeting COVID-19 and the flu.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants receive a single intramuscular injection of mRNA-1083 (Lot A, B, C, or D) on Day 1
Treatment Part 2
Participants receive a single intramuscular injection of mRNA-1083 (Lot A or E) on Day 1
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- mRNA-1083
Find a Clinic Near You
Who Is Running the Clinical Trial?
ModernaTX, Inc.
Lead Sponsor
Dr. Stephen Hoge
ModernaTX, Inc.
Chief Medical Officer
MD from Harvard Medical School
Stéphane Bancel
ModernaTX, Inc.
Chief Executive Officer since 2011
MBA from Harvard Business School, MSc in Engineering from École Centrale Paris