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Yellow Fever

Phase 3

Dengue | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Mar 25, 2022

Target and mechanism

ModalityMonoclonal antibody

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment1,182

FDA Designations

No designations recorded

Clinical trial landscape

Yellow Fever · 2 trials · 4 indications

Phase 3 1Phase 2 1
NCT01436396Study of Yellow Fever Vaccine Administered With Tetravalent Dengue Vaccine in Healthy ToddlersDengue
COMPLETED792 Analytics
PHASE3COMPLETED
Study of Yellow Fever Vaccine Administered With Tetravalent Dengue Vaccine in Healthy Toddlers
DengueUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Flavi Virus (FV) Non-immune Participants With Seroconversion Against YF Antigen After Vaccination With Yellow Fever (YF) Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
28 days Post-Injection 1

Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies \>=10 (1/dilution \[dil\]) in flavivirus non-immune participants (defined as those with YF antibodies \<10 \[1/dil\] for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus).

Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Pre-injection 1, 28 days and 6 months post-injection 3

GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test (PRNT).

Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Pre-injection 1, 28 days and 6 months post-injection 3

Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer \>=10 (1/dilution).

Secondary Endpoints

Percentage of All Participants With Seroconversion Against YF Antigen After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
28 days Post-Injection 1
Geometric Mean Titers (GMTs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Pre-Injection 1 and 28-days Post-Injection 1
Geometric Mean Titer Ratios (GMTRs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Pre-Injection 1 and 28- days Post-Injection 1
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
CYD Dengue Vaccine GroupEXPERIMENTALParticipants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (Month \[M\] 0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP-IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
Placebo GroupEXPERIMENTALParticipants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
CYD Dengue vaccine: Group 1EXPERIMENTALParticipants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
CYD Dengue vaccine: Group 2EXPERIMENTALParticipants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
CYD Dengue and Yellow Fever vaccine: Group 3EXPERIMENTALParticipants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
Yellow Fever vaccine: Group 4ACTIVE_COMPARATORParticipants received single dose of YF vaccine at Day 0.

Interventions

NameTypeDescription
Live, attenuated dengue serotype 1, 2, 3, and 4 virusBIOLOGICAL0.5 mL, subcutaneous at age 12, 18, and 24 months
Yellow fever vaccineBIOLOGICAL0.5 mL subcutaneous in the deltoid at age 12 to 13 months.
Measles, mumps, and rubella (MMR) vaccineBIOLOGICAL0.5 mL, subcutaneous at age 12 to 13 months.
Pneumococcal Conjugated VaccineBIOLOGICAL0.5 mL, intramuscular at age 13 to 14 months
Hepatitis A Pediatric VaccineBIOLOGICAL0.5 mL, intramuscular at age 13 to 14 months and 25 to 26 months
Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccineBIOLOGICAL0.5 mL, intramuscular at age 19 to 20 months
Placebo (NaCl)BIOLOGICAL0.5 mL, subcutaneous at age 12 to 13 months
Measles, mumps, and rubella vaccineBIOLOGICAL0.5 mL, subcutaneous at age 13 to 14 months
Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virusBIOLOGICAL0.5 mL, Subcutaneous
Yellow FeverBIOLOGICAL0.5 mL, Subcutaneous
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Eligibility Criteria

Age Range12 Months to 13 Months
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Aged 12 to 13 months on the day of inclusion. * Born at full term of pregnancy (\>=37 weeks) and with a birth weight \>=2.5 kg as reported by the parent/legally acceptable representative. * Participant in good health, based on medical history and physical examination. * Partic...

Countries:ColombiaPeruUnited States
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Frequently asked questions about Yellow Fever

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.