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Pandemic flu H5 mRNA vaccine

Phase 1

Influenza Immunization | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Apr 23, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment276

FDA Designations

No designations recorded

Clinical trial landscape

Pandemic flu H5 mRNA vaccine · 1 trial · 1 indication

Phase 1 1
NCT06727058Study to Evaluate Safety and Immunogenicity of a Pandemic Flu H5 mRNA Vaccine in Healthy Adults Aged 18 Years and OlderInfluenza Immunization
COMPLETED276 Analytics
PHASE1COMPLETED
Study to Evaluate Safety and Immunogenicity of a Pandemic Flu H5 mRNA Vaccine in Healthy Adults Aged 18 Years and Older
Influenza ImmunizationUnlock trial analytics

Study Endpoints

Primary Endpoints

Presence of immediate adverse events (AEs) within 30 minutes after each/any injection
Within 30 minutes of any/each injections

Number of participants experiencing immediate AEs

Presence of solicited injection site reactions through 7 days after each/any injection
Through 7 days after each/any injections

Number of participants experiencing solicited injection site reactions

Presence of solicited systemic site reactions through 7 days after each/any injection
Through 7 days after each/any injections

Number of participants experiencing solicited systemic site reactions

Presence of unsolicited AEs through 21 days after the first injection and through 28 days after the second injection
Through 21 days after the first injection and through 28 days after the second injection

Number of participants experiencing unsolicited AEs

Presence of medically attended adverse events (MAAEs) through 180 days after the last injection
Through 180 days after the last injection

Number of participants experiencing MAAEs

Presence of adverse events of special interest (AESIs) throughout the study
Throughout the study, approximately 13 months

Number of participants experiencing AESIs

Presence of serious adverse events (SAEs) throughout the study
Throughout the study, approximately 13 months

Number of participants experiencing SAEs

Presence of out-of-range biological test results (including shift from baseline values) through a maximum of 8 days after each injection
Through a maximum of 8 days after each injection

Number of participants with out-of-range biological test results

Secondary Endpoints

Antibody titers measured by Hemagglutination Inhibition (HAI) Assay
At Day 01, Day 22, Day 43, Day 112, and Day 202
Individual HAI titer ratio
At Day 22/Day 01, Day 43/Day 01, Day 112/Day 01, and Day 202/Day 01
≥ 4-fold increase in HAI titer [1/dilution])
At Day 22 or Day 43
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1: Low Dose Pandemic flu H5 mRNA vaccineEXPERIMENTALParticipants will receive 2 injections of pandemic flu H5 mRNA vaccine 21 days apart (at Day 01 and Day 22)
Group 2: Medium Dose Pandemic flu H5 mRNA vaccineEXPERIMENTALParticipants will receive 2 injections of pandemic flu H5 mRNA vaccine 21 days apart (at Day 01 and Day 22)
Group 3: High Dose Pandemic flu H5 mRNA vaccineEXPERIMENTALParticipants will receive 2 injections of pandemic flu H5 mRNA vaccine 21 days apart (at Day 01 and Day 22)
Group 4: PlaceboPLACEBO_COMPARATORParticipants will receive 2 injections of placebo 21 days apart (at Day 01 and Day 22)

Interventions

NameTypeDescription
Pandemic flu H5 mRNA vaccineBIOLOGICALPharmaceutical Form: Suspension for injection Route of Administration: Intramuscular (IM)
PlaceboOTHERPharmaceutical Form: Liquid solution for injection Route of Administration: Intramuscular (IM)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites14

Inclusion Criteria: * Aged 18 years or older on the day of inclusion. * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: * Is of non-childbearing potential. To be considered of non-childbearing potential, a femal...

Countries:United States
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Frequently asked questions about Pandemic flu H5 mRNA vaccine

What is Pandemic flu H5 mRNA vaccine used for?

Pandemic flu H5 mRNA vaccine is an investigational vaccine for influenza immunization. It is designed to protect against pandemic flu caused by the H5 influenza strain. The vaccine is currently in Phase 1 clinical development and is not yet approved for use.

Who makes Pandemic flu H5 mRNA vaccine?

Pandemic flu H5 mRNA vaccine is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. The vaccine is currently in Phase 1 clinical trials for influenza immunization.

What phase is Pandemic flu H5 mRNA vaccine in?

Pandemic flu H5 mRNA vaccine is in Phase 1 clinical development. It is an investigational vaccine for influenza immunization and has not been approved by regulatory authorities. A Phase 1 trial has been completed to evaluate its safety and immunogenicity.

What clinical trials is Pandemic flu H5 mRNA vaccine in?

Pandemic flu H5 mRNA vaccine has one completed Phase 1 trial, NCT06727058, which evaluated its safety and immunogenicity in healthy adults aged 18 years and older in the United States. The trial enrolled 276 participants and was randomized, double-blind, and placebo-controlled.

Is Pandemic flu H5 mRNA vaccine the same as a flu shot?

Pandemic flu H5 mRNA vaccine is an investigational mRNA vaccine specifically designed for pandemic flu caused by the H5 strain. It is not the same as a seasonal flu shot, which targets different strains. The vaccine is still in clinical development and not yet available to the public.