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Vaccine Candidate #1

Phase 2

Healthy Adults | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: May 6, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment770

FDA Designations

No designations recorded

Clinical trial landscape

Vaccine Candidate #1 · 1 trial · 1 indication

Phase 2 1
NCT07431853A Study to Learn About mRNA Vaccines Against Influenza in AdultsHealthy Adults
RECRUITING770 Analytics
PHASE2RECRUITING
A Study to Learn About mRNA Vaccines Against Influenza in Adults
Healthy Adults
NCT07431853770
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Study Endpoints

Primary Endpoints

Percentage of participants reporting prespecified local reactions following vaccination
Within 7 days after vaccination
Percentage of participants reporting prespecified systemic events following vaccination.
Within 7 days after vaccination
Percentage of participants reporting adverse events (AEs) following vaccination.
Within 1 month after vaccination
Percentage of participants reporting serious adverse events (SAEs) following vaccination.
Within 6 months after vaccination
Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs) following vaccination.
Within 6 months after vaccination

Secondary Endpoints

Geometric Mean Titer (GMT) of Anti-Influenza Antibody Levels to each of the influenza antigens of the vaccine.
Before vaccination and at 4 weeks after vaccination
Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to each of the influenza antigens of the vaccine
Before vaccination to 4 weeks after vaccination
Percentage of participants with satisfactory antibody response to the vaccine.
Before vaccination to 4 weeks after vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
AEXPERIMENTALmRNA influenza vaccine candidate #1 as a single intramuscular (IM) injection on Day 1.
BEXPERIMENTALmRNA influenza vaccine candidate #2 as a single IM injection on Day 1.
CEXPERIMENTALmRNA influenza vaccine candidate #3 as a single IM injection on Day 1.
DEXPERIMENTALmRNA influenza vaccine candidate #4 as a single IM injection on Day 1.
EEXPERIMENTALmRNA influenza vaccine candidate #5 as a single IM injection on Day 1.
FEXPERIMENTALmRNA influenza vaccine candidate #6 as a single IM injection on Day 1.
GACTIVE_COMPARATORLicensed influenza vaccine (TIV1 or TIV2) as a single IM injection.

Interventions

NameTypeDescription
Vaccine Candidate #1BIOLOGICALInvestigational influenza Vaccine
Vaccine Candidate #2BIOLOGICALInvestigational influenza Vaccine
Vaccine Candidate #3BIOLOGICALInvestigational Influenza Vaccine
Vaccine Candidate #4BIOLOGICALInvestigational Influenza Vaccine
Vaccine Candidate #5BIOLOGICALInvestigational Influenza Vaccine
Vaccine Candidate #6BIOLOGICALInvestigational Influenza Vaccine
TIV1 or TIV2BIOLOGICALLicensed influenza vaccine
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites15

Inclusion Criteria • Healthy and medically stable participants who are determined by medical history, physical examination (if clinically required), and clinical judgment of the investigator to be eligible for inclusion in the study. Exclusion Criteria * Tested positive for influenza ≤5 months (1...

Countries:United States
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