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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06431607 | A Study to Find the Dose and Assess the Immune Response and Safety of a Vaccine Against Influenza in Healthy Younger and Older Adults | PHASE2 | COMPLETED | 845 | — | — | May 23, 2024 | Jun 4, 2025 | Mar 10, 2026 | 18 | United States |
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer \< 1:10 and a post-dose anti-vaccine antibody titer \>= 1:40 or a pre-dose anti-vaccine antibody titer \>= 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer \< 1:10 and a post-dose anti-vaccine antibody titer \>= 1:40 or a pre-dose anti-vaccine antibody titer \>= 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer \< 1:10 and a post-dose anti-vaccine antibody titer \>= 1:40 or a pre-dose anti-vaccine antibody titer \>= 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer \< 1:10 and a post-dose anti-vaccine antibody titer \>= 1:40 or a pre-dose anti-vaccine antibody titer \>= 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer \>= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer \>= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer \>= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer \>= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer \>= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
| Arm | Type | Description |
|---|---|---|
| Part 1 YA: Flu mRNA_1_Younger Adults (YA) | EXPERIMENTAL | YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1. |
| Part 1 YA: Flu mRNA_2_YA | EXPERIMENTAL | YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1. |
| Part 1 YA: Flu mRNA_3_YA | EXPERIMENTAL | YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1. |
| Part 1 YA: Flu mRNA_4_YA | EXPERIMENTAL | YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1. |
| Part 1 YA: Comparator_1_YA | ACTIVE_COMPARATOR | YA participants received a single dose of Comparator 1 \[FDQ23A-NH (Flu D-QIV)\] administered at Day 1. |
| Part 2 YA: Flu mRNA_9_YA | EXPERIMENTAL | YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1. |
| Part 2 YA: Comparator_2_YA | ACTIVE_COMPARATOR | YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1. |
| Part 1 OA: Flu mRNA_5_Older Adults (OA) | EXPERIMENTAL | OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1. |
| Part 1 OA: Flu mRNA_6_OA | EXPERIMENTAL | OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1. |
| Part 1 OA: Flu mRNA_7_OA | EXPERIMENTAL | OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1. |
| Part 1 OA: Flu mRNA_8_OA | EXPERIMENTAL | OA participants received a single dose of Flu mRNA study intervention F2H23G/DL001Z administered at Day 1. |
| Part 1 OA: Comparator_1_OA | ACTIVE_COMPARATOR | OA participants received a single dose of Comparator 1 (Fluzone HD Quadrivalent) administered at Day 1. |
| Part 2 OA: Flu mRNA_10_OA | EXPERIMENTAL | OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1. |
| Part 2 OA: Comparator_2_OA | ACTIVE_COMPARATOR | OA participants received a single dose of Comparator 2 (Fluzone HD) administered at Day 1. |
| Name | Type | Description |
|---|---|---|
| F2G22B/DL001Z | BIOLOGICAL | Study intervention was administered intramuscularly at Day 1. |
| F2H23D/DL001Z-NH | BIOLOGICAL | Study intervention was administered intramuscularly at Day 1. |
| F2H23B/DL001Z-NH | BIOLOGICAL | Study intervention was administered intramuscularly at Day 1. |
| F2H23H/DL001Z | BIOLOGICAL | Study intervention was administered intramuscularly at Day 1. |
| FDQ23A-NH (Flu D-QIV) | COMBINATION_PRODUCT | Control Vaccine was administered intramuscularly at Day 1. |
| GSK5800544A | BIOLOGICAL | Study intervention was administered intramuscularly at Day 1. |
| Flu D-TIV | COMBINATION_PRODUCT | Control Vaccine was administered intramuscularly at Day 1. |
| F2H23A/DL001Z-NH | BIOLOGICAL | Study intervention was administered intramuscularly at Day 1. |
| F2H23G/DL001Z | BIOLOGICAL | Study intervention was administered intramuscularly at Day 1. |
| Fluzone HD Quadrivalent | COMBINATION_PRODUCT | Control vaccine was administered intramuscularly at Day 1. |
| Fluzone HD | COMBINATION_PRODUCT | Control vaccine was administered intramuscularly at Day 1. |
Inclusion Criteria: 1. A male or female between and including 18 and 85 years of age (YAs: 18-64; OAs: 65-85) at the time of the study intervention administration. 2. Healthy participants or medically stable patients as established by medical history and clinical examination. Participants with chro...