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Also known as Flu mRNA (Formulation A), Flu mRNA (Formulation B1), GSK4382276A Dose level 1, GSK4382276A Dose level 2, GSK4382276A Dose level 3, GSK4382276A Dose level 4, GSK4382276A Dose level 5, GSK4382276A Dose level 6
Flu mRNA · 2 trials · 1 indication
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. 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.
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.
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 mRNA_1_YA | EXPERIMENTAL | Eligible Younger Adults (YA) participants receive a single dose of Flu mRNA Formulation B1 (GSK6498032A) as study intervention at Day 1. |
| Flu mRNA_3_YA | EXPERIMENTAL | Eligible YA participants receive a single dose of Flu mRNA Formulation B3 (GSK6498032A) as study intervention at Day 1. |
| Flu mRNA_4_YA | EXPERIMENTAL | Eligible YA participants receive a single dose of Flu mRNA Formulation A (GSK6479720A) as study intervention at Day 1. |
| Comparator_1_YA | ACTIVE_COMPARATOR | Eligible YA participants receive a single dose of comparator 1 at Day 1. |
| Comparator_2_YA | ACTIVE_COMPARATOR | Eligible YA participants receive a single dose of comparator 2 at Day 1. |
| Flu mRNA_1_OA | EXPERIMENTAL | Eligible Older Adults (OA) participants receive a single dose of Flu mRNA Formulation B1 (GSK6498032A) as study intervention at Day 1. |
| Flu mRNA_3_OA | EXPERIMENTAL | Eligible YA participants receive a single dose of Flu mRNA Formulation B3 (GSK6498032A) as study intervention at Day 1. |
| Flu mRNA_4_OA | EXPERIMENTAL | Eligible YA participants receive a single dose of Flu mRNA Formulation A (GSK6479720A) as study intervention at Day 1. |
| Comparator_1_OA | EXPERIMENTAL | Eligible OA participants receive a single dose of comparator 1 at Day 1. |
| Comparator_2_OA | ACTIVE_COMPARATOR | Eligible OA participants receive a single dose of comparator 3 at Day 1. |
| Flu mRNA_2_YA | EXPERIMENTAL | Eligible YA participants receive a single dose of Flu mRNA Formulation B (GSK6479715A) as study intervention at Day 1. |
| Flu mRNA_2_OA | EXPERIMENTAL | Eligible OA participants receive a single dose of Flu mRNA Formulation B (GSK6479715A) as study intervention at Day 1. |
| Comparator_3_OA | ACTIVE_COMPARATOR | Eligible OA participants receive a single dose of comparator 3 at Day 1. |
| Name | Type | Description |
|---|---|---|
| Flu mRNA (Formulation B1) | BIOLOGICAL | One dose of Flu mRNA (Formulation B1) received intramuscularly. |
| Flu mRNA (Formulation B3) | BIOLOGICAL | One dose of Flu mRNA (Formulation B3) received intramuscularly. |
| Flu mRNA(Formulation A) | BIOLOGICAL | One dose of Flu mRNA (Formulation A) received intramuscularly. |
| Comparator 1 | COMBINATION_PRODUCT | One dose of Comparator 1 received intramuscularly. |
| Comparator 2 | COMBINATION_PRODUCT | One dose of Comparator 2 received intramuscularly. |
| Comparator 3 | COMBINATION_PRODUCT | One dose of Comparator 3 received intramuscularly. |
| Flu mRNA (Formulation A) | BIOLOGICAL | One dose of Flu mRNA (Formulation A) received intramuscularly. |
| Flu mRNA (Formulation B) | BIOLOGICAL | One dose of Flu mRNA (Formulation B) received intramuscularly. |
Inclusion Criteria: 1. Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, attendance to study contacts and study site visits, and ability to access and utilize a phone or other electronic communications) ...
Flu mRNA is an investigational messenger RNA vaccine developed by GSK plc for the prevention of human influenza. It is designed to prompt an immune response against influenza virus in adults. It is a Phase 2 candidate and has not been approved for use. Two completed Phase 2 trials have evaluated it in healthy adult volunteers.
Flu mRNA is being studied for the prevention of influenza in humans. Its clinical program has enrolled adults 18 years of age and older, including healthy volunteers, in the United States and Belgium. The two completed Phase 2 trials assessed immune response and safety in this population.
Flu mRNA is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating the vaccine in human influenza, including the two completed Phase 2 studies registered as NCT07204964 and NCT07121192.
Flu mRNA is in Phase 2 clinical development. Both of its registered trials are Phase 2 studies and both are completed, with no trials currently active. It is an investigational vaccine and has not been approved by the FDA or any other regulator for the prevention of influenza.
Flu mRNA has been evaluated in two completed Phase 2 trials. NCT07204964 enrolled 971 adults aged 18 and above in the United States and Belgium. NCT07121192 enrolled 776 adults aged 18 and older in the United States. Both were randomized, double-blind, and actively controlled, with a combined enrollment of 1,747 participants.
Yes. Flu mRNA (Formulation A) and Flu mRNA (Formulation B1) are alternative names for the same GSK influenza mRNA vaccine program. Searches using any of these names refer to the same Phase 2 candidate being studied for the prevention of human influenza.