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Flu Pandemic mRNA_Dose level 1

Phase 1

Influenza, Human | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Feb 5, 2026

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment991
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06382311A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older AdultsPHASE1 COMPLETED 991Apr 18, 2024Jan 13, 2026Feb 5, 202621 United States
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Study Endpoints
Primary Endpoints
Percentage of participants with solicited administration site events [Phase 1 and Phase 2 Part A]
From Day 1 to Day 7

The assessed solicited administration site events are pain at administration site, redness at administration site, swelling at administration site and lymphadenopathy.

Percentage of participants with solicited systemic events [Phase 1 and Phase 2 Part A]
From Day 1 to Day 7

The assessed solicited systemic events are fever, headache, myalgia, arthralgia, fatigue, and chills. Fever is defined as temperature greater than or equal to (\>=)38 degrees Celsius (°C)/ 100.4 Fahrenheit (°F) regardless the location of measurement.

Percentage of participants with unsolicited adverse events (AEs) [Phase 1 and Phase 2 Part A]
From Day 1 to Day 21

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. Unsolicited AEs include both serious and nonserious AEs.

Percentage of participants with medically attended adverse events (MAAEs) [Phase 1 and Phase 2 Part A]
From Day 1 to Day 203

An MAAE is defined as an unsolicited AE for which the participant receives medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider.

Percentage of participants with serious adverse events (SAEs) [Phase 1 and Phase 2 Part A]
From Day 1 to Day 203

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, abnormal pregnancy outcomes, is a suspected transmission of any infectious agent via an authorized medicinal product.

Percentage of participants with adverse events of special interest (AESIs) [Phase 1 and Phase 2 Part A]
From Day 1 to Day 203

Events considered as AESIs are severe hypersensitivity reactions and myocarditis/pericarditis.

Phase 1: Percentage of participants with increase in FDA toxicity grading for hematology and clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 8
Baseline (Day 1), Day 8
Phase 1: Percentage of participants with increase in FDA toxicity grading in hematology and clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 29
Baseline (Day 1), Day 29
Phase 1: Percentage of participants with increase in haematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 8
Baseline (Day 1), Day 8
Phase 1: Percentage of participants with increase in hematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 29
Baseline (Day 1), Day 29
Percentage of participants with anti- hemagglutinin inhibition (HI) titers ≥ 1:40 at Day 43 [Phase 1 and Phase 2 Part A]
At Day 43
Percentage of participants with solicited administration site events [Phase 2 Part B]
From Day 1 to Day 7

The assessed solicited administration site events are pain at administration site, redness at administration site, swelling at administration site and lymphadenopathy.

Percentage of participants with solicited systemic events [Phase 2 Part B]
From Day 1 to Day 7

The assessed solicited systemic events are fever, headache, myalgia, arthralgia, fatigue, and chills. Fever is defined as temperature \>= 38°C/100.4°F regardless the location of measurement. The preferred location for measuring temperature is axillary.

Percentage of participants with unsolicited AEs [Phase 2 Part B]
From Day 1 to Day 21

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. Unsolicited AEs include both serious and nonserious AEs.

Percentage of participants with MAAEs [Phase 2 Part B]
From Day 1 to Day 203

MAAE is defined as an unsolicited AE for which the participant receives medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider.

Percentage of participants with SAEs [Phase 2 Part B]
From Day 1 to Day 203

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, abnormal pregnancy outcomes, is a suspected transmission of any infectious agent via an authorized medicinal product.

Percentage of participants with AESIs [Phase 2 Part B]
From Day 1 to Day 203

Events considered as AESIs are severe hypersensitivity reactions, Aminotransferase (AT) elevation and myocarditis/pericarditis.

Percentage of participants with increase in FDA toxicity grading for clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 8 [Phase 2 Part B]
Baseline (Day 1), Day 8
Percentage of participants with increase in FDA toxicity grading for clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 29 [Phase 2 Part B]
Baseline (Day 1), Day 29
Percentage of participants with increase in clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 8 [Phase 2 Part B]
Baseline (Day 1), Day 8
Percentagev of participants with increase in clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 29 [Phase 2 Part B]
Baseline (Day 1), Day 29
Percentage of participants with anti-HI titers ≥ 1:40 at Day 43 [Phase 2 Part B]
At Day 43
Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B]
At Day 43 compared to pre-vaccination (Day 1, pre-dosing)

HI seroconversion is defined as a post-dose titer ≥1:40 in the serum of participants with pre-dose titer below 1:10 or as a ≥4-fold rise in post dose HI titers with pre- dose titer ≥1:10.

GMT Ratio of anti-HI antibody titers [Phase 2 Part B]
At Day 43
Secondary Endpoints
Geometric mean titers (GMTs) of HI antibody titers [Phase 1 and Phase 2 Part A]
At Day 1, Day 22, Day 29, Day 43, and Day 203
Geometric mean increase (GMI) of HI antibody titers [Phase 1 and Phase 2 Part A]
At Day 22 compared to pre-vaccination (Day 1, pre-dosing)
Geometric mean increase (GMI) of anti-HI antibody titers [Phase 1 and Phase 2 Part A]
At Day 29 compared to pre-vaccination (Day 1, pre-dosing)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Flu mRNA_Ph1_1_YAEXPERIMENTALYA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 1 during Phase 1, at Day 1 and at Day 22.
Flu mRNA_Ph1_2_YAEXPERIMENTALYA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 2 during Phase 1, at Day 1 and at Day 22.
Flu mRNA_Ph1_3_YAEXPERIMENTALYA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 3 during Phase 1, at Day 1 and at Day 22.
Flu mRNA_Ph1_4_YAEXPERIMENTALYA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 4 during Phase 1, at Day 1 and at Day 22.
Flu mRNA_Ph1_5_YAEXPERIMENTALYA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 5 during Phase 1, at Day 1 and at Day 22.
Placebo_Ph1_YAPLACEBO_COMPARATORYA participants receive 2 doses of Placebo during Phase 1, at Day 1 and at Day 22.
Flu mRNA_Ph1_1_OAEXPERIMENTALOA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 1 during Phase 1, at Day 1 and at Day 22.
Flu mRNA_Ph1_2_OAEXPERIMENTALOA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 2 during Phase 1, at Day 1 and at Day 22.
Flu mRNA_Ph1_3_OAEXPERIMENTALOA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 3 during Phase 1, at Day 1 and at Day 22.
Flu mRNA_Ph1_4_OAEXPERIMENTALOA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 4 during Phase 1, at Day 1 and at Day 22.
Flu mRNA_Ph1_5_OAEXPERIMENTALOA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 5 during Phase 1, at Day 1 and at Day 22.
Placebo_Ph1_OAPLACEBO_COMPARATOROA Adult participants receive 2 doses of Placebo during Phase 1, at Day 1 and at Day 22.
Flu mRNA_Ph2_1_YA Part AEXPERIMENTALYA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 1 during Phase 2 Part A, at Day 1 and at Day 22.
Flu mRNA_Ph2_2_YA Part AEXPERIMENTALYA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 2 during Phase 2 Part A, at Day 1 and at Day 22.
Flu mRNA_Ph2_3_YA Part AEXPERIMENTALYA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 3 during Phase 2 Part A, at Day 1 and at Day 22.
Flu mRNA_Ph2_4_YA Part AEXPERIMENTALYA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 4 during Phase 2 Part A, at Day 1 and at Day 22.
Flu mRNA_Ph2_5_YA Part AEXPERIMENTALYA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 5 during Phase 2 Part A, at Day 1 and at Day 22.
Placebo_Ph2_YA Part APLACEBO_COMPARATORYA participants receive 2 doses of Placebo during Phase 2 Part A, at Day 1 and at Day 22.
Flu mRNA_Ph2_1_OA Part AEXPERIMENTALOA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 1 during Phase 2 Part A, at Day 1 and at Day 22.
Flu mRNA_Ph2_2_OA Part AEXPERIMENTALOA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 2 during Phase 2 Part A, at Day 1 and at Day 22.
Flu mRNA_Ph2_3_OA Part AEXPERIMENTALOA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 3 during Phase 2 Part A, at Day 1 and at Day 22.
Flu mRNA_Ph2_4_OA Part AEXPERIMENTALOA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 4 during Phase 2 Part A, at Day 1 and at Day 22.
Flu mRNA_Ph2_5_OA Part AEXPERIMENTALOA participants receive 2 doses of Flu Pandemic mRNA\_Dose level 5 during Phase 2 Part A, at Day 1 and at Day 22.
Placebo_Ph2_OA Part APLACEBO_COMPARATOROA participants receive 2 doses of Placebo during Phase 2 Part A, at Day 1 and at Day 22.
Flu mRNA_Ph2 Part BEXPERIMENTALParticipants receive 2 dose of Flu Pandemic mRNA dose level 6 in Phase 2 Part B, at Day 1 and at Day 22.
Influenza Virus Vaccine_Ph2 Part BACTIVE_COMPARATORParticipants receive 2 doses of influenza virus vaccine administered in Phase 2 Part B, at Day 1 and at Day 22.
Placebo_Ph2 Part BPLACEBO_COMPARATORParticipants receive 2 doses of Placebo during Phase 2 Part B, at Day 1 and at Day 22.
Interventions
NameTypeDescription
Flu Pandemic mRNA_Dose level 1BIOLOGICAL2 doses of study intervention are administered to participants intramuscularly.
Flu Pandemic mRNA_Dose level 2BIOLOGICAL2 doses of study intervention are administered to participants intramuscularly.
Flu Pandemic mRNA_ Dose level 3.BIOLOGICAL2 doses of study intervention are administered to participants intramuscularly.
Flu Pandemic mRNA_ Dose level 4BIOLOGICAL2 doses of study intervention are administered to participants intramuscularly.
Flu Pandemic mRNA_Dose level 5BIOLOGICAL2 doses of study intervention are administered to participants intramuscularly.
Flu Pandemic mRNA_Dose level 6BIOLOGICAL2 dose of study intervention is administered to participants intramuscularly.
Influenza virus vaccineBIOLOGICAL2 doses of Influenza virus vaccine are administered to participants intramuscularly.
PlaceboDRUG2 doses of Placebo are administered intramuscularly to participants in Phase 1 and Phase 2 Part A and 2 dose is administered to participants in Phase 2 Part B.
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersYes
Study Sites21

Inclusion Criteria: * A male or female between and including 18 and 64 yoa (i.e., 64 years + 364 days; YAs) or between and including 65 and 85 yoa (i.e., 85 years + 364 days; OAs) at the time of the first study intervention administration. * Participants, who, in the opinion of the investigator, ca...

Countries:United States
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