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F2C22C/DL001Z

Phase 1

Influenza, Human | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jul 23, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment1,275
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05823974A Study to Assess the Safety and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older AdultsPHASE1 COMPLETED 1,275Apr 27, 2023Dec 18, 2024Jul 23, 202541 United States, Belgium +2
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Study Endpoints
Primary Endpoints
Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Day 1 to Day 7

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.

Number of Participants Reporting Any Solicited Systemic AEs
Day 1 to Day 7

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.

Number of Participants Reporting Any Unsolicited AEs
Day 1 to Day 28

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.

Number of Participants Reporting Serious Adverse Events (SAEs)
Day 1 to Day 183

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.

Number of Participants Reporting AEs of Special Interest (AESIs)
Day 1 to Day 183

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.

Number of Participants Reporting Medically Attended Events (MAEs)
Day 1 to Day 183

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.

Number of Participants Reporting a Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 8 for Hematology, and Clinical Chemistry
At Day 8 compared to baseline (Day 1)

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.

Number of Participants Reporting a Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 29 for Hematology, and Clinical Chemistry
At Day 29 compared to baseline (Day 1)

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.

Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
At Day 29

Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.

Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers From Day 1 to Day 29
From Day 1 (baseline) to Day 29

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.

Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
From Day 1 to Day 29

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.

Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
At Day 1

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.

Percentage of Participants With Antigen 1 Antibody SPR
At Day 29

Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.

GMT of Antigen 2 Antibody Titer
At Day 29
GMI of Antigen 2 Antibody Titer From Day 1 to Day 29
From Day 1 (baseline) to Day 29
Percentage of Participants With Antigen 2 Antibody SCR
From Day 1 to Day 29
Secondary Endpoints
GMT of Antigen 1 Antibody Titer
At Day 92
GMI of Antigen 1 Antibody Titer From Day 1 to Day 92
From Day 1 (baseline) to Day 92
GMI of Antigen 1 Antibody Titer From Day 1 to Day 183
From Day 1 (baseline) to Day 183
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Flu mRNA_Ph1_1 Younger Adults (YA) GroupEXPERIMENTALYA 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 GroupEXPERIMENTALYA 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 GroupEXPERIMENTALYA 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 GroupEXPERIMENTALYA 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 GroupEXPERIMENTALYA 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 GroupEXPERIMENTALYA 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 GroupEXPERIMENTALYA 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 GroupEXPERIMENTALYA 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 GroupEXPERIMENTALYA 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 GroupEXPERIMENTALYA 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 GroupEXPERIMENTALYA 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 GroupEXPERIMENTALYA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
Control Ph1_YA GroupACTIVE_COMPARATORYA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
Flu mRNA_Ph2_1_YA GroupEXPERIMENTALYA 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 GroupEXPERIMENTALYA 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 GroupEXPERIMENTALYA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
Control_Ph2_YA GroupACTIVE_COMPARATORYA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
Flu mRNA_Ph2_1_Older adults (OA) GroupEXPERIMENTALOA 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 GroupEXPERIMENTALOA 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 GroupEXPERIMENTALOA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
Control_Ph2_OA GroupACTIVE_COMPARATOROA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
Interventions
NameTypeDescription
F2C22C/DL001ZBIOLOGICALStudy intervention was administered intramuscularly in Phase 1, at Day 1.
F2B22A/DL001ZBIOLOGICALStudy intervention was administered intramuscularly in Phase 1, at Day 1.
F2B22B/DL001ZBIOLOGICALStudy intervention was administered intramuscularly in Phase 1, at Day 1.
F2B22C/DL001ZBIOLOGICALStudy intervention was administered intramuscularly in Phase 1, at Day 1.
F2B22D/DL001ZBIOLOGICALStudy intervention was administered intramuscularly in Phase 1, at Day 1.
F2B22E/DL001ZBIOLOGICALStudy intervention was administered intramuscularly in Phase 1, at Day 1.
F2F22A/DL001ZBIOLOGICALStudy intervention was administered intramuscularly in Phase 1, at Day 1.
F2F22B/DL001ZBIOLOGICALStudy intervention was administered intramuscularly in Phase 1, at Day 1.
F2F22C/DL001ZBIOLOGICALStudy intervention was administered intramuscularly in Phase 1, at Day 1.
F2F22D/DL001ZBIOLOGICALStudy intervention was administered intramuscularly in Phase 1, at Day 1.
F2F22E/DL001ZBIOLOGICALStudy intervention was administered intramuscularly in Phase 1, at Day 1.
Control 1COMBINATION_PRODUCTControl vaccine was administered intramuscularly in Phase 1, at Day 1.
F2F23D/DL001Z-NHBIOLOGICALStudy intervention was administered intramuscularly in Phase 2, at Day 1.
F2F23A/DL001Z-NHBIOLOGICALStudy intervention was administered intramuscularly in Phase 2, at Day 1.
F2F23B/DL001Z-NHBIOLOGICALStudy intervention was administered intramuscularly in Phase 2, at Day 1.
Control 2COMBINATION_PRODUCTControl vaccine was administered intramuscularly in Phase 2, at Day 1.
F2F23C/DL001Z-NHBIOLOGICALStudy intervention was administered intramuscularly in Phase 2, at Day 1.
Control 3COMBINATION_PRODUCTControl vaccine was administered intramuscularly in Phase 2, at Day 1.
F2F22F/DL001ZBIOLOGICALStudy intervention was administered intramuscularly in Phase 1, at Day 1.
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersYes
Study Sites41

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...

Countries:United StatesBelgiumCanadaSouth Africa
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