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Flu Seasonal /SARS-CoV-2 mRNA Dose 1

Phase 1

COVID-19 | RNA therapy | Infectious Disease |GSK plc|Last Updated: Sep 11, 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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment106
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06680375A Study of an Investigational Flu Seasonal/SARS-CoV-2 Combination Vaccine in AdultsPHASE1 COMPLETED 106Nov 11, 2024Jun 9, 2025Sep 11, 20259 United States
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Study Endpoints
Primary Endpoints
Percentage of participants with increase in grading for at least one laboratory value from administration of study intervention
From Day 1 to Day 8

Food and Drug Administration (FDA) toxicity grading scales for biochemistry hematology parameters are evaluated. Grades are defined as follows: Grade 1 - Mild; Grade 2 - Moderate; Grade 3 - Severe; Grade 4 -Potentially life threatening.

Percentage of participants with solicited administration site adverse events (AEs)
From Day 1 to Day 7

The AEs considered are pain, redness, swelling and lymphadenopathy.

Percentage of participants with solicited systemic AEs
From Day 1 to Day 7

The 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.

Percentage of participants with unsolicited AEs
From Day 1 to Day 28

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.

Percentage of participants with medically attended adverse events (MAAEs)
From Day 1 to Day 183 (study end)

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.

Percentage of participants with serious adverse events (SAEs)
From Day 1 to Day 183 (study end)

A 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.

Percentage of participants with adverse events of special interest (AESIs)
From Day 1 to Day 183 (study end)

The following events are considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs).

Geometric mean titer (GMT) ratio of antigen 1 antibody for investigational mRNA Flu/COVID-19 (pooled dose 1 and dose 2) and mRNA flu vaccines
At Day 29
GMT ratio of antigen 2 antibody for investigational mRNA Flu/COVID-19 (pooled dose 1 and dose 2) and mRNA flu seasonal vaccines
At Day 29
GMT ratio of serum neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s) for investigational mRNA Flu/COVID-19 (pooled dose 1 and dose 2) and mRNA COVID-19 vaccines
At Day 29
Secondary Endpoints
GMT ratio of antigen 1 antibody for the investigational mRNA Flu/COVID-19 vaccines (dose 1 and 2) and Flu vaccines (pooled group) and licensed Flu vaccine co-administered with a licensed mRNA COVID-19 vaccine
At Day 29
GMT ratio of antigen 2 antibody for the investigational mRNA Flu/COVID-19 vaccines (dose 1 and 2) and Flu vaccines (pooled group) and licensed Flu vaccine co-administered with a licensed mRNA COVID-19 vaccine
At Day 29
GMT ratio of serum neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s)
At Day 29
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
mRNA Flu/COVID-19 Dose 1 GroupEXPERIMENTALParticipants receive one dose of investigational Flu mRNA vaccine composition in combination with a Dose 1 of a COVID-19 component and 1 dose of placebo on Day 1.
mRNA Flu/COVID-19 Dose 2 GroupEXPERIMENTALParticipants receive one dose of a Flu mRNA vaccine composition in combination with a Dose 2 of a COVID-19 component and 1 dose of placebo on Day 1.
Flu+COVID-19 GroupACTIVE_COMPARATORParticipants receive one dose of a licensed Flu Seasonal vaccine and a licensed mRNA COVID-19 vaccine on Day 1.
mRNA Flu GroupACTIVE_COMPARATORParticipants receive one dose of an investigational mRNA Flu Seasonal vaccine and 1 dose of placebo on Day 1.
mRNA COVID-19 Dose 1 GroupACTIVE_COMPARATORParticipants receive one dose of Dose 1 investigational mRNA COVID-19 vaccine and 1 dose of placebo on Day 1.
mRNA COVID-19 Dose 2 GroupACTIVE_COMPARATORParticipants receive one Dose 2 investigational mRNA COVID-19 vaccine and 1 dose of placebo on Day 1.
Interventions
NameTypeDescription
Flu Seasonal /SARS-CoV-2 mRNA Dose 1COMBINATION_PRODUCTA Flu mRNA vaccine composition in combination with Dose 1 of a COVID-19 component will be administered.
Flu Seasonal /SARS-CoV-2 mRNA Dose 2COMBINATION_PRODUCTA Flu mRNA vaccine composition in combination with Dose 2 of a COVID-19 component will be administered.
Flu Seasonal mRNACOMBINATION_PRODUCTAn investigational mRNA Flu Seasonal vaccine will be administered.
SARS-CoV-2 mRNA Dose 1COMBINATION_PRODUCTDose 1 of an investigational mRNA COVID-19 vaccine will be administered.
SARS-CoV-2 mRNA Dose 2COMBINATION_PRODUCTDose 2 of an investigational mRNA COVID-19 vaccine will be administered.
Licensed Flu SeasonalCOMBINATION_PRODUCTA licensed Flu Seasonal vaccine will be administered.
Licensed COVID-19 mRNACOMBINATION_PRODUCTA licensed mRNA COVID-19 vaccine will be administered.
PlaceboDRUGA placebo will be administered.
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersYes
Study Sites9

Inclusion Criteria: * Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits). * Written informed consent obtained from the participant prior to performance of any study-specific p...

Countries:United States
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