Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Yellow fever vaccine (produced on serum-free Vero cells), Yellow Fever, Yellow fever vaccine (live), Stamaril, YF-VAX
Yellow fever vaccine · 5 trials · 3 indications
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)
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
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
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
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
Immediate adverse events are any unsolicited systemic adverse events reported in the 30 minutes after vaccination
Solicited injection site reactions include injection site pain, erythema and swelling
Solicited systemic reactions include fever, headache, malaise and myalgia
Unsolicited (spontaneously reported) AEs, not fulfilling criteria for solicited adverse reactions
MAAEs
AESIs
SAEs
Seroconversion was defined as a 4-fold increase in Nab titers as compared to the pre-vaccination value. YF-naive participants (or negative) at baseline corresponded to participants with no detectable YF Ab titers before vaccination. The YF NAb titers were determined using a validated live virus microneutralization (MN) assay. Percentages are rounded off to the tenth decimal place.
Unsolicited (spontaneously reported) adverse events not fulfilling criteria for solicited adverse reactions
Grade 3 fever is defined as temperature ≥ 102.1°F
Serious adverse events are collected throughout the study
Hematology and biochemistry values that are out-of-range are assessed
Investigators are provided with guidelines for recognition and assessment of potential viscerotropic and neurotropic events
Seroconversion is defined as a fourfold increase in neutralizing antibody titers as compared to pre-vaccination value. Seroconversion is assessed from Day 0 (pre-vaccination) to Day 10, Day 14 and Day 28.
Pre-defined threshold of 10 1/dilution
Geometric mean titer ratio Day 10/Day 0, Day 14/Day 0, Day 28/Day 0 and Day 180/Day 0
Vaccinal viremia is measured by YF specific quantitative reverse transcription polymerase chain reaction (RT-PCR) assay in samples collected on Day 0, Day 1, Day 3, Day 5, Day 7, Day 10, and Day 14.
Vaccinal viremia is measured by YF specific quantitative RT-PCR assay in samples collected on Day 0, Day 1, Day 3, Day 5, Day 7, Day 10, and Day 14.
| Arm | Type | Description |
|---|---|---|
| vYF | EXPERIMENTAL | One single dose of vYF will be administered subcutaneously at the 1st visit |
| Group 1 (9-24 months) | EXPERIMENTAL | Primary 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_COMPARATOR | Primary 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_COMPARATOR | Primary 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) | EXPERIMENTAL | Primary vaccination phase: 1 injection of vYF vaccine at Day 1 |
| Group 5 (2-5 years) | ACTIVE_COMPARATOR | Primary vaccination phase: 1 injection of Stamaril vaccine at Day 1 |
| Group 6 (2-5 years) | ACTIVE_COMPARATOR | Primary vaccination phase: 1 injection of YF-VAX vaccine at Day 1 |
| Group 7 (approximately 11-15 months) | EXPERIMENTAL | Primary vaccination phase: 1 injection of MMR vaccine at Day 1 in a cohort of 11 to 15 months of age vaccinated with vYF |
| vYF vaccine | EXPERIMENTAL | A single dose on Day 01 |
| YF-VAX vaccine | ACTIVE_COMPARATOR | A single dose on Day 01 |
| Group 1 | EXPERIMENTAL | 1 injection of vYF vaccine at Day 1 |
| Group 2 | ACTIVE_COMPARATOR | 1 injection of Stamaril vaccine at Day 1 |
| Group 3 | EXPERIMENTAL | 1 injection of vYF vaccine Dosage 3 |
| Group 4 | ACTIVE_COMPARATOR | 1 injection of YF-VAX |
| Name | Type | Description |
|---|---|---|
| Yellow fever vaccine (live) | BIOLOGICAL | Pharmaceutical form:Powder and diluent for suspension for injection-Route of administration:Subcutaneous |
| Measles, combinations with mumps and rubella, live attenuated | BIOLOGICAL | Powder, lyophilized, for suspension for reconstitution Subcutaneous or intermuscular |
| YF vaccine (live) | BIOLOGICAL | Powder and diluent for suspension for injection Subcutaneous |
| Yellow fever vaccine (produced on serum-free Vero cells) | BIOLOGICAL | Powder and diluent for suspension for injection - Subcutaneous |
| Yellow fever vaccine | BIOLOGICAL | Powder and diluent for suspension for injection - Subcutaneous |
| Yellow fever vaccine (produced on serum-free Vero cells), Dosage 1 vYF vaccine | BIOLOGICAL | Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous |
| Yellow fever vaccine (produced on serum-free Vero cells), Dosage 2 vYF vaccine | BIOLOGICAL | Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous |
| Yellow fever vaccine (produced on serum-free Vero cells), Dosage 3 vYF vaccine | BIOLOGICAL | Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous |
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...
The yellow fever vaccine is used to prevent yellow fever, a mosquito-borne viral infection. The investigational vaccine described here, known as vYF, is being developed for yellow fever immunization in both adults and children. It is intended to protect against infection by inducing an immune response to the yellow fever virus.
The vYF yellow fever vaccine is developed by Sanofi, which trades under the ticker SNY. Sanofi is conducting Phase 3 clinical trials of this vaccine candidate in multiple countries, including the United States, Japan, Honduras, Mexico, and Panama.
The vYF yellow fever vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by the FDA. The Phase 3 program includes three trials, two of which are completed and one that is currently recruiting participants.
The vYF yellow fever vaccine has been studied in several clinical trials. Completed Phase 3 trials include NCT07222059 in Japan and NCT07002060 in the United States. An ongoing Phase 3 trial, NCT07103148, is recruiting pediatric participants in Honduras, Mexico, and Panama. An earlier Phase 2 trial, NCT05011123, was conducted in Europe and Asia.
Yes, vYF is an alternative name for the investigational yellow fever vaccine produced on serum-free Vero cells. Other names used for this vaccine candidate include Dosage 1 vYF vaccine and yellow fever vaccine (live). These names refer to the same Sanofi-developed vaccine candidate.