Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mRNA Seasonal Flu vaccine · 2 trials · 1 indication
First occurrence of laboratory-confirmed protocol-defined ILI caused by influenza A subtypes and B lineage. Protocol-defined ILI is defined as the simultaneous occurrence of at least 1 respiratory symptom and at least 1 systemic symptom. Respiratory symptoms include nasal congestion, sore throat, new or increased sputum, new or increased cough, new or increased dyspnea, or wheezing. Systemic symptoms include temperature \>37.2°C/99°F or feverishness, fatigue, myalgia, or headache. The endpoint will be assessed using an incidence rate approach. Relative vaccine efficacy will be calculated as 100 × (1 - incidence rate ratio).
The solicited administration site AEs considered are pain, redness, swelling and lymphadenopathy. Lymphadenopathy is defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm.
The solicited systemic AEs considered are fever, headache, fatigue, myalgia, arthralgia and chills. Fever is defined as temperature greater than or equal to (\>=) 38 °C/100.4 °F regardless the location of measurement.
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.
| Arm | Type | Description |
|---|---|---|
| mRNA Seasonal Flu Vaccine - Cohort 1 | EXPERIMENTAL | Participants 18 to 64 years of age will receive a single dose of investigational mRNA Seasonal Flu vaccine on Day 1. |
| Comparator 1_Cohort 1 | ACTIVE_COMPARATOR | Participants 18 to 64 years of age will receive a single dose of comparator 1 on Day 1. |
| mRNA Seasonal Flu Vaccine - Cohort 2 | EXPERIMENTAL | Participants 60 to 64 years of age will receive a single dose of investigational mRNA Seasonal Flu vaccine on Day 1. |
| Comparator 2_Cohort 2 | ACTIVE_COMPARATOR | Participants 60 to 64 years of age will receive a single dose of comparator 2 on Day 1. |
| mRNA Seasonal Flu Vaccine | EXPERIMENTAL | Participants will receive a single dose of investigational mRNA Seasonal Flu vaccine on Day 1. |
| Active Comparator | ACTIVE_COMPARATOR | Participants will receive a single dose of an age-appropriate and season-adapted licensed influenza vaccine Day 1. |
| Name | Type | Description |
|---|---|---|
| mRNA Seasonal Flu vaccine | BIOLOGICAL | One dose of the mRNA Flu vaccine received intramuscularly. |
| Comparator 1 | BIOLOGICAL | One dose of the comparator vaccine received intramuscularly. |
| Comparator 2 | BIOLOGICAL | One dose of the comparator vaccine received intramuscularly. |
| Licensed Influenza Vaccine | COMBINATION_PRODUCT | Single-dose intramuscular administration of an age-appropriate and season-adapted licensed influenza vaccine used as the active comparator. |
Inclusion Criteria: * Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits, attendance to study contacts, and ability to access and utilize a phone or other electronic communicati...
It is an investigational vaccine designed to protect against seasonal influenza in adults. GSK plc is developing it using mRNA technology, and it is currently in Phase 3 clinical development. It is not yet approved for use, and its safety and efficacy are still being evaluated in ongoing trials.
It is being developed for the prevention of influenza in humans. The Phase 3 program is testing it in adults 18 to 64 years of age and in adults 65 years of age and older. It is an investigational vaccine and has not been approved for any indication.
GSK plc, which trades under the ticker GSK, is the developer of the mRNA seasonal flu vaccine. The company is running the Phase 3 clinical program for the vaccine in the United States, studying it in younger and older adult populations.
The GSK mRNA seasonal flu vaccine is in Phase 3 clinical development. Two Phase 3 trials are currently recruiting, and neither has been completed. The vaccine remains investigational and has not received regulatory approval for the prevention of seasonal influenza.
Two Phase 3 trials are recruiting. NCT07851246 is evaluating immune response and safety in adults 18 to 64 years of age, with about 3,000 participants. NCT07805707 is studying efficacy in adults 65 years of age and older, with about 54,000 participants. Both are randomized, double-blind, and active-controlled.
The two Phase 3 trials together plan to enroll about 57,000 participants. NCT07851246 accounts for roughly 3,000 adults aged 18 to 64, while NCT07805707 accounts for about 54,000 adults aged 65 and older. Both studies are randomized, double-blind, and active-controlled.