About this trial
This early-stage study will look at a new mRNA vaccine that combines defenses against both seasonal flu and COVID-19 in terms of its safety and how it builds protection. Healthy adults aged 65 to 85 will receive different doses of this new vaccine, a standard flu vaccine, or COVID-19 vaccine. The study will assess any side effects or health issues, and additional blood samples will be collected at specific times to evaluate how well participants bodies build protection against the flu and COVID-19.
Eligibility criteria
Qualifiers
Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol independently or with the assistance of the caregiver.
Informed consent obtained from the participant prior to performance of any study-specific procedure.
A male or female 65 to 85 years of age (YoA) (inclusive) at the time of screening.
Healthy participants or medically stable patients as established by medical history and clinical examination.
Disqualifiers
Any clinically significant laboratory abnormality.
History of symptomatic influenza/ SARS-CoV-2 infection confirmed by local health authority-approved testing methods within 180 days (for influenza) or 90 days (SARS-CoV-2 infection) prior to study intervention administration.
History of Guillain-Barré syndrome (GBS) within 6 weeks of receiving any vaccine.
Current or past malignancy, unless completely resolved without clinically significant sequelae (e.g., no evidence of disease following successful treatment of basal cell carcinoma cases are allowed) for >5 years.
Trial design
Treatments tested in this trial
- Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine
- Licensed Seasonal Influenza Vaccine
- Licensed COVID-19 Vaccine