Phase 1 Study to Evaluate Safety and Immune Response of a New mRNA Seasonal Flu and COVID-19 Combination Vaccine in Adults Aged 65 to 85

What this Trial Is About

Researchers are evaluating a new mRNA vaccine that combines protection against both seasonal flu and COVID-19 in healthy adults aged 65 to 85 years. This early-stage Phase 1 study aims to assess the safety and immune response of this investigational vaccine compared to standard licensed flu and COVID-19 vaccines. The study is focused on measuring side effects and how well the vaccine builds protection against both infections. Participants will receive a single intramuscular injection of either one of three dose levels of the investigational mRNA combination vaccine, a licensed seasonal flu vaccine, or a licensed COVID-19 vaccine. The study groups are randomized and observer-blind. The investigational vaccine is given as a single dose, with three different dosage levels being tested sequentially for safety and immune response. During the study, participants will be monitored for side effects from the day of vaccination through several time points up to 181 days. Blood samples will be collected at specified intervals to evaluate immune responses against flu and COVID-19. The main measures include the number of participants experiencing laboratory abnormalities and adverse events, as well as immune protection markers such as antibody levels and seroconversion rates. The total participation spans from vaccination day through about six months of follow-up.

A Study on the Safety and Immune Response of Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults