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.
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.
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.
Sequential
Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine
Biological/VaccineFlu/COVm Vaccine with multiple dose levels (Dose Level 1, Dose Level 2, and Dose Level 3), will be administered via single intramuscular injection.
Licensed Seasonal Influenza Vaccine
Biological/VaccineLicense Seasonal Influenza Vaccine will be administered as a single intramuscular dose.
Licensed COVID-19 Vaccine
Biological/VaccineLicensed COVID-19 Vaccine will be administered as a single intramuscular dose.
Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities Following Administration of the Study Intervention
The assessed toxicity grades for laboratory value abnormalities will be defined as follows: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Potentially life-threatening.
Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities following Administration of Study Intervention
Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities following Administration of Study Intervention
Number of Participants with Solicited Administration Site Adverse Events (AEs)
The solicited administration site AEs considered are pain, redness, swelling and lymphadenopathy.
Geometric Mean Titer (GMT) Of Antigen 1 Titer
Percentage of Participants with Antigen 1 Seroconversion Rate (SCR)
Percentage of Participants with Antigen 1 Seroprotection Rate (SPR)
Geometric Mean Increase (GMI) of Antigen 1 Titer
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