| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05823974 | A Study to Assess the Safety and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults | PHASE1 | COMPLETED | 1,275 | — | — | Apr 27, 2023 | Dec 18, 2024 | Jul 23, 2025 | 41 | United States, Belgium +2 |
Assessed solicited administration site events included pain, redness (Erythema), swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Assessed solicited systemic events included fever (defined as axillary temperature greater than or equal to (\>=) 38.0°C/100.4°F), chills, headache, fatigue, myalgia, and arthralgia. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
An unsolicited AE is defined as 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. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
The following events were considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs). Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physician's office visits, emergency room visits or hospitalization). Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
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.
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.
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
| Arm | Type | Description |
|---|---|---|
| Flu mRNA_Ph1_1 Younger Adults (YA) Group | EXPERIMENTAL | YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1. |
| Flu mRNA_Ph1_2 YA Group | EXPERIMENTAL | YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1. |
| Flu mRNA_Ph1_3 YA Group | EXPERIMENTAL | YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1. |
| Flu mRNA_Ph1_4 YA Group | EXPERIMENTAL | YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1. |
| Flu mRNA_Ph1_5 YA Group | EXPERIMENTAL | YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1. |
| Flu mRNA_Ph1_6 YA Group | EXPERIMENTAL | YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1. |
| Flu mRNA_Ph1_7 YA Group | EXPERIMENTAL | YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1. |
| Flu mRNA_Ph1_8 YA Group | EXPERIMENTAL | YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1. |
| Flu mRNA_Ph1_9 YA Group | EXPERIMENTAL | YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1. |
| Flu mRNA_Ph1_10 YA Group | EXPERIMENTAL | YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1. |
| Flu mRNA_Ph1_11 YA Group | EXPERIMENTAL | YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1. |
| Flu mRNA_Ph1_12 YA Group | EXPERIMENTAL | YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1. |
| Control Ph1_YA Group | ACTIVE_COMPARATOR | YA participants received a single dose of Control 1 administered in Phase 1, at Day 1. |
| Flu mRNA_Ph2_1_YA Group | EXPERIMENTAL | YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1. |
| Flu mRNA_Ph2_2_YA Group | EXPERIMENTAL | YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1. |
| Flu mRNA_Ph2_3_YA Group | EXPERIMENTAL | YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1. |
| Control_Ph2_YA Group | ACTIVE_COMPARATOR | YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1. |
| Flu mRNA_Ph2_1_Older adults (OA) Group | EXPERIMENTAL | OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1. |
| Flu mRNA_Ph2_2_OA Group | EXPERIMENTAL | OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1. |
| Flu mRNA_Ph2_3_OA Group | EXPERIMENTAL | OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1. |
| Control_Ph2_OA Group | ACTIVE_COMPARATOR | OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1. |
| Name | Type | Description |
|---|---|---|
| F2C22C/DL001Z | BIOLOGICAL | Study intervention was administered intramuscularly in Phase 1, at Day 1. |
| F2B22A/DL001Z | BIOLOGICAL | Study intervention was administered intramuscularly in Phase 1, at Day 1. |
| F2B22B/DL001Z | BIOLOGICAL | Study intervention was administered intramuscularly in Phase 1, at Day 1. |
| F2B22C/DL001Z | BIOLOGICAL | Study intervention was administered intramuscularly in Phase 1, at Day 1. |
| F2B22D/DL001Z | BIOLOGICAL | Study intervention was administered intramuscularly in Phase 1, at Day 1. |
| F2B22E/DL001Z | BIOLOGICAL | Study intervention was administered intramuscularly in Phase 1, at Day 1. |
| F2F22A/DL001Z | BIOLOGICAL | Study intervention was administered intramuscularly in Phase 1, at Day 1. |
| F2F22B/DL001Z | BIOLOGICAL | Study intervention was administered intramuscularly in Phase 1, at Day 1. |
| F2F22C/DL001Z | BIOLOGICAL | Study intervention was administered intramuscularly in Phase 1, at Day 1. |
| F2F22D/DL001Z | BIOLOGICAL | Study intervention was administered intramuscularly in Phase 1, at Day 1. |
| F2F22E/DL001Z | BIOLOGICAL | Study intervention was administered intramuscularly in Phase 1, at Day 1. |
| Control 1 | COMBINATION_PRODUCT | Control vaccine was administered intramuscularly in Phase 1, at Day 1. |
| F2F23D/DL001Z-NH | BIOLOGICAL | Study intervention was administered intramuscularly in Phase 2, at Day 1. |
| F2F23A/DL001Z-NH | BIOLOGICAL | Study intervention was administered intramuscularly in Phase 2, at Day 1. |
| F2F23B/DL001Z-NH | BIOLOGICAL | Study intervention was administered intramuscularly in Phase 2, at Day 1. |
| Control 2 | COMBINATION_PRODUCT | Control vaccine was administered intramuscularly in Phase 2, at Day 1. |
| F2F23C/DL001Z-NH | BIOLOGICAL | Study intervention was administered intramuscularly in Phase 2, at Day 1. |
| Control 3 | COMBINATION_PRODUCT | Control vaccine was administered intramuscularly in Phase 2, at Day 1. |
| F2F22F/DL001Z | BIOLOGICAL | Study intervention was administered intramuscularly in Phase 1, at Day 1. |
Inclusion Criteria: * A male or female between and including 18 and 50 years of age in Phase 1 and between and including 18 and 85 years of age (YA: 18-64; OA: 65-85) in Phase 2 at the time of the study intervention administration. * Healthy participants or medically stable participants as establis...