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Yellow fever vaccine

Phase 3

Yellow Fever | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: May 6, 2026

Target and mechanism

ModalityMonoclonal antibody

Also known as Yellow fever vaccine (produced on serum-free Vero cells), Yellow fever vaccine (live)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment254

FDA Designations

No designations recorded

Clinical trial landscape

Yellow fever vaccine · 3 trials · 2 indications

Phase 3 3
NCT07222059Phase 3 Single Arm, Open Study on vYF in AdultsYellow Fever
COMPLETED254 Analytics
NCT07103148A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric PopulationYellow Fever Immunization
RECRUITING2,440 Analytics
NCT07002060Phase 3 Randomized, Modified Double-blind, Active-controlled Safety Study on vYF in AdultsYellow Fever Immunization
COMPLETED640 Analytics
PHASE3COMPLETED
Phase 3 Single Arm, Open Study on vYF in Adults
Yellow FeverUnlock trial analytics
PHASE3RECRUITING
A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population
Yellow Fever ImmunizationUnlock trial analytics
PHASE3COMPLETED
Phase 3 Randomized, Modified Double-blind, Active-controlled Safety Study on vYF in Adults
Yellow Fever ImmunizationUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of participants with seroconversion to YF virus in YF-naive participants
28 days after one dose of vYF vaccine

Seroconversion rates will be assessed using a YF MN assay Seroconversion is defined as a 4-fold increase in neutralizing Ab (NAb) titers as compared to the pre-vaccination value (Day 01)

Percentage of participants with seroconversion to YF virus after 1 dose of vYF compared to seroconversion after 1 dose of the Stamaril in YF-naive participants (9-24 months)
At Day 29, 28 days post-vaccination (on Day 01) with vYF or Stamaril

Seroconversion rates will be assessed using a YF MN assay Seroconversion is defined as a 4-fold increase in NAb titers as compared to the pre-vaccination value

Percentage of participants with seroconversion to YF virus after 1 dose of vYF compared to seroconversion after 1 dose of the YF-VAX in YF-naive participants (9-24 months)
At Day 29, 28 days post-vaccination (on Day 01) with vYF or YF-VAX

Seroconversion rates will be assessed using a YF MN assay Seroconversion is defined as a 4-fold increase in NAb titers as compared to the pre-vaccination value

Percentage of participants with seroconversion to YF virus after 1 dose of vYF compared to seroconversion after 1 dose of the Stamaril in YF-naive participants (2-5 years)
At Day 29, 28 days post-vaccination (on Day 01) with vYF or Stamaril

Seroconversion rates will be assessed using a YF MN assay Seroconversion is defined as a 4-fold increase in NAb titers as compared to the pre-vaccination value

Percentage of participants with seroconversion to YF virus after 1 dose of vYF compared to seroconversion after 1 dose of the YF-VAX in YF-naive participants (2-5 years)
At Day 29, 28 days post-vaccination (on Day 01) with vYF or YF-VAX

Seroconversion rates will be assessed using a YF MN assay Seroconversion is defined as a 4-fold increase in NAb titers as compared to the pre-vaccination value

Number of participants with immediate adverse events
Within 30 minutes after vaccination

Immediate adverse events are any unsolicited systemic adverse events reported in the 30 minutes after vaccination

Number of participants with solicited injection site reactions
Up to 7 days after vaccination

Solicited injection site reactions include injection site pain, erythema and swelling

Number of participants with solicited systemic reactions
Up to 14 days after vaccination

Solicited systemic reactions include fever, headache, malaise and myalgia

Number of participants with unsolicited adverse events (AEs)
Up to 28 days after vaccination

Unsolicited (spontaneously reported) AEs, not fulfilling criteria for solicited adverse reactions

Number of participants with medical attended adverse events (MAAEs)
Up to 28 days after vaccination

MAAEs

Number of participants with adverse events of special interest (AESIs)
Up to 6 months after vaccination

AESIs

Number of participants with serious adverse events (SAEs)
Up to 6 months after vaccination

SAEs

Secondary Endpoints

Percentage of participants with seroprotection to YF virus
At Day 01 and Day 29
Percentage of participants with seroconversion to YF virus
28 days after one dose of vYF vaccine
Geometric Mean Titers (GMTs) of neutralizing antibodies against YF virus
At Day 01 and Day 29
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
vYFEXPERIMENTALOne single dose of vYF will be administered subcutaneously at the 1st visit
Group 1 (9-24 months)EXPERIMENTALPrimary vaccination phase: 1 injection of vYF vaccine at Day 1 Booster phase: 1 injection of vYF vaccine at Year 3 (in a subset)
Group 2 (9-24 months)ACTIVE_COMPARATORPrimary vaccination phase: 1 injection of Stamaril vaccine at Day 1 Booster phase: 1 injection of Stamaril vaccine at Year 3 (in a subset)
Group 3 (9-24 months)ACTIVE_COMPARATORPrimary vaccination phase: 1 injection of YF-VAX vaccine at Day 1 Booster phase: 1 injection of YF-VAX vaccine at Year 3 (in a subset)
Group 4 (2-5 years)EXPERIMENTALPrimary vaccination phase: 1 injection of vYF vaccine at Day 1
Group 5 (2-5 years)ACTIVE_COMPARATORPrimary vaccination phase: 1 injection of Stamaril vaccine at Day 1
Group 6 (2-5 years)ACTIVE_COMPARATORPrimary vaccination phase: 1 injection of YF-VAX vaccine at Day 1
Group 7 (approximately 11-15 months)EXPERIMENTALPrimary vaccination phase: 1 injection of MMR vaccine at Day 1 in a cohort of 11 to 15 months of age vaccinated with vYF
vYF vaccineEXPERIMENTALA single dose on Day 01
YF-VAX vaccineACTIVE_COMPARATORA single dose on Day 01

Interventions

NameTypeDescription
Yellow fever vaccine (live)BIOLOGICALPharmaceutical form:Powder and diluent for suspension for injection-Route of administration:Subcutaneous
Measles, combinations with mumps and rubella, live attenuatedBIOLOGICALPowder, lyophilized, for suspension for reconstitution Subcutaneous or intermuscular
YF vaccine (live)BIOLOGICALPowder and diluent for suspension for injection Subcutaneous
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Aged from 18 years on the day of inclusion\* \* "From 18 years" means from the day of the 18th birthday * Participants who are healthy as determined by medical evaluation including medical history and physical examination. * Able to attend all scheduled visits and to comply...

Countries:JapanHondurasMexicoPanamaUnited States
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Frequently asked questions about Yellow fever vaccine

What is Yellow Fever vaccine used for?

Yellow Fever vaccine is used for immunization against yellow fever, a viral infection transmitted by mosquitoes. It is also being studied for use in dengue prevention. The vaccine is indicated for yellow fever immunization in adults and pediatric populations, and clinical trials are evaluating its safety and immunogenicity.

Who makes Yellow Fever vaccine?

Sanofi (ticker: SNY) is developing the Yellow Fever vaccine. The vaccine is produced on serum-free Vero cells and is a live attenuated vaccine. Sanofi is conducting Phase 3 clinical trials to evaluate its safety and immunogenicity in various populations.

What phase is Yellow Fever vaccine in?

Yellow Fever vaccine is in Phase 3 clinical development. Multiple Phase 3 trials are ongoing or completed, including studies in adults and pediatric populations. The vaccine is investigational and not yet approved for widespread use.

What clinical trials is Yellow Fever vaccine in?

Yellow Fever vaccine is being studied in several clinical trials. NCT07103148 is a Phase 3 study in pediatric populations in Honduras, Mexico, and Panama. NCT07002060 and NCT07222059 are Phase 3 studies in adults. NCT01488890 is a Phase 2 study evaluating immune response with a dengue vaccine.

Is Yellow Fever vaccine the same as yellow fever vaccine?

Yes, Yellow Fever vaccine is also known as yellow fever vaccine (produced on serum-free Vero cells) and yellow fever vaccine (live). These names refer to the same investigational vaccine being developed by Sanofi for yellow fever immunization.

How does Yellow Fever vaccine work?

Yellow Fever vaccine is a live attenuated vaccine, meaning it contains a weakened form of the yellow fever virus. This stimulates the immune system to produce a protective response without causing the disease. It is being studied for its ability to provide immunity against yellow fever and potentially cross-protect against dengue.