Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Flu/COVID-19 mRNA combination vaccine · 1 trial · 1 indication
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.
The solicited administration site AEs considered are pain, redness, swelling and lymphadenopathy.
The solicited systemic AEs considered are fever, headache, fatigue, myalgia, arthralgia and chills.
An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
A SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment.
The following events are considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, Aminotransferase elevation; myocarditis/pericarditis within 6 weeks after study intervention administration and potential immune-mediated diseases (pIMDs).
A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional.
| Arm | Type | Description |
|---|---|---|
| FLU/COVm_Dose Level 1 | EXPERIMENTAL | Participants receive a single intramuscular administration of the investigational mRNA Seasonal Flu/COVID-19 combination vaccine at dose level 1 (Lowest dose). |
| FLU/COVm_Dose Level 2 | EXPERIMENTAL | Participants receive a single intramuscular administration of the investigational mRNA Seasonal Flu/COVID-19 combination vaccine at dose level 2 (Medium dose). |
| FLU/COVm_Dose Level 3 | EXPERIMENTAL | Participants receive a single intramuscular administration of the investigational mRNA Seasonal Flu/COVID-19 combination vaccine at dose level 3 (Highest dose). |
| Licensed Seasonal Influenza Vaccine Group | ACTIVE_COMPARATOR | Participants receive a single intramuscular administration of a licensed seasonal Flu vaccine. |
| Licensed COVID-19 Vaccine Group | ACTIVE_COMPARATOR | Participants receive a single intramuscular administration of a licensed COVID-19 vaccine. |
| Name | Type | Description |
|---|---|---|
| Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine | BIOLOGICAL | Flu/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 | License Seasonal Influenza Vaccine will be administered as a single intramuscular dose. |
| Licensed COVID-19 Vaccine | BIOLOGICAL | Licensed COVID-19 Vaccine will be administered as a single intramuscular dose. |
Inclusion Criteria: 1. 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. 2. Informed consent obtained from the participant prior to performance of any study-specific procedure. 3. A...