Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07204964 | A Study to Evaluate the Immune Response and Safety of an Influenza Vaccine in Adults 18 Years of Age and Above | PHASE2 | ACTIVE NOT_RECRUITING | 971 | — | — | Oct 7, 2025 | Jul 31, 2026 | Mar 27, 2026 | 17 | United States, Belgium |
| NCT07121192 | A Study to Assess the Immune Response and Safety of a Vaccine Against Influenza in Adults 18 Years of Age and Older | PHASE2 | COMPLETED | 776 | — | — | Aug 25, 2025 | May 11, 2026 | May 28, 2026 | 22 | United States |
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) ...