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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1217-1958 | Other Identifier | UTN |
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The primary objectives of the study are:
Study duration per participant is approximately 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 1 injection of vYF vaccine Dosage 1 |
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| Group 2 | Experimental | 1 injection of vYF vaccine Dosage 2 |
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| Group 3 | Experimental | 1 injection of vYF vaccine Dosage 3 |
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| Group 4 | Active Comparator | 1 injection of YF-VAX |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with immediate adverse events | Immediate adverse events are any unsolicited systemic adverse events reported in the 30 minutes after vaccination | Within 30 minutes after vaccination |
| Number of participants with solicited injection site reactions | Solicited injection site reactions include injection site pain, erythema and swelling | Within 7 days after vaccination |
| Number of participants with solicited systemic reactions | Solicited systemic reactions include fever, headache, malaise, and myalgia | Within 14 days after vaccination |
| Number of participants with unsolicited adverse events | Unsolicited (spontaneously reported) adverse events not fulfilling criteria for solicited adverse reactions | Within 28 days after vaccination |
| Number of participants with Grade 3 fever | Grade 3 fever is defined as temperature ≥ 102.1°F | Within 28 days after vaccination |
| Number of participants with serious adverse events | Serious adverse events are collected throughout the study | From Day 0 to Day 180 |
| Number of participants with hematology and biochemistry out-of-range test results | Hematology and biochemistry values that are out-of-range are assessed |
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Inclusion criteria :
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 8400001 | Silver Spring | Maryland | 20910 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39293214 | Derived | Pagnon A, Carre C, Aguirre M, Chautard E, Gimenez S, Raynal F, Feroldi E, Scott P, Modjarrad K, Vangelisti M, Mantel N. Next generation yellow fever vaccine induces an equivalent immune and transcriptomic profile to the current vaccine: observations from a phase I randomised clinical trial. EBioMedicine. 2024 Oct;108:105332. doi: 10.1016/j.ebiom.2024.105332. Epub 2024 Sep 17. |
| Label | URL |
|---|---|
| VYF01 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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An observer-blind procedure is followed for the injection of vYF or YF-VAX. Neither the observer Investigator, nor the Sponsor, nor the participants know product is administered. The "vaccinator" is in charge of preparing and administering the products and is not authorized to collect any safety data.
| 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 |
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| 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 |
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| Yellow fever vaccine | Biological | Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous |
|
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| From Day 0 to Day 14 |
| Number of participants with YF and flavivirus viremia and out-of-normal-range biological test results in the event of severe fever, or suspicion of neurotropic disease or acute viscerotropic diseases | Investigators are provided with guidelines for recognition and assessment of potential viscerotropic and neurotropic events | Within 28 days after vaccination |
| Number of participants with seroconversion to YF virus | 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. | From Day 0 to Day 28 |
| Number of participants with neutralizing antibody titers against YF virus above pre-defined threshold | Pre-defined threshold of 10 1/dilution | From Day 0 to Day 180 |
| Geometric mean titers of neutralizing antibodies against YF virus | Geometric mean titer ratio Day 10/Day 0, Day 14/Day 0, Day 28/Day 0 and Day 180/Day 0 | From Day 0 to Day 180 |
| Number of participants with YF vaccinal viremia | 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. | From Day 0 to Day 14 |
| Level of YF vaccinal viremia | 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. | From Day 0 to Day 14 |
| ID | Term |
|---|---|
| D015004 | Yellow Fever |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
| D014777 | Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
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| ID | Term |
|---|---|
| D022341 | Yellow Fever Vaccine |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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