Approval Probability
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Adjusted LOA
ML Risk
Licensed Seasonal Influenza 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...
Licensed Seasonal Influenza Vaccine is an investigational mRNA combination vaccine being studied for the prevention of influenza and COVID-19 in adults. It is designed to target both seasonal flu and SARS-CoV-2, the virus that causes COVID-19, in a single vaccine.
Licensed Seasonal Influenza Vaccine is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is currently conducting a Phase 1 clinical trial to evaluate the vaccine's safety and immune response.
Licensed Seasonal Influenza Vaccine is in Phase 1 clinical development. It is an investigational vaccine that has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess its safety and immunogenicity.
Licensed Seasonal Influenza Vaccine is being evaluated in a single Phase 1 trial with the identifier NCT07464314. This randomized, double-blind, active-controlled study is enrolling 225 adults aged 65 years and older in the United States to assess the safety and immune response of the mRNA seasonal flu/COVID-19 combination vaccine.
Licensed Seasonal Influenza Vaccine is an mRNA-based vaccine that works by delivering genetic instructions to cells to produce antigens from both influenza viruses and SARS-CoV-2. This stimulates the immune system to produce protective antibodies against both pathogens, potentially offering combined protection against seasonal flu and COVID-19.