A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population
NCT ID: NCT07103148
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
2440 participants
INTERVENTIONAL
2025-07-11
2030-03-04
Brief Summary
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Number of Participants:
A total of 2440 participants is planned to be enrolled in VYF04 study.
Study Arms and Duration:
Eligible participants will be randomized in 2 independent groups (9-24 months, 2-5 years) to receive 1 dose of either vYF or Stamaril or YF-VAX in a 2:1:1 ratio within each age group. An additional group with participants of 11-15 months of age will also receive at the same vaccination visit vYF and a single dose of MMR vaccine.
For the 2nd step (YF booster vaccine administration in a subset), at the Year (Y) 3 visit, a subset of 120 participants of the 9-24 months of age group who did receive a YF vaccine on Day(D) 01 will be invited to join a booster dose assessment (booster dose administered after the Y3 visit blood sample has been taken). Participants aged 11 to 15 months at the time of the concomitant administration of vYF and MMR will not be eligible for receiving a booster dose.
The duration of each participation will be approximately 3 years for all participants (including participants co-administered on D01 with vYF and MMR), and 6 more months post-booster dose administration for the participants enrolled in the booster subset.
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Detailed Description
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The Phase III VYF04 is the first study to be carried out with the investigational vYF in pediatric populations.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
* Only the study staff who prepare and administer the study interventions and are not involved with the safety evaluation will know which study intervention is administered.
Study Groups
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Group 1 (9-24 months)
Primary vaccination phase: 1 injection of vYF vaccine at Day 1 Booster phase: 1 injection of vYF vaccine at Year 3 (in a subset)
Yellow fever vaccine (live)
Powder and diluent for suspension for injection Subcutaneous
Group 2 (9-24 months)
Primary vaccination phase: 1 injection of Stamaril vaccine at Day 1 Booster phase: 1 injection of Stamaril vaccine at Year 3 (in a subset)
Yellow fever vaccine (live)
Powder and diluent for suspension for injection Subcutaneous
Group 3 (9-24 months)
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)
Yellow fever vaccine (live)
Powder and diluent for suspension for injection Subcutaneous
Group 4 (2-5 years)
Primary vaccination phase: 1 injection of vYF vaccine at Day 1
Yellow fever vaccine (live)
Powder and diluent for suspension for injection Subcutaneous
Group 5 (2-5 years)
Primary vaccination phase: 1 injection of Stamaril vaccine at Day 1
Yellow fever vaccine (live)
Powder and diluent for suspension for injection Subcutaneous
Group 6 (2-5 years)
Primary vaccination phase: 1 injection of YF-VAX vaccine at Day 1
Yellow fever vaccine (live)
Powder and diluent for suspension for injection Subcutaneous
Group 7 (approximately 11-15 months)
Primary vaccination phase: 1 injection of MMR vaccine at Day 1 in a cohort of 11 to 15 months of age vaccinated with vYF
Yellow fever vaccine (live)
Powder and diluent for suspension for injection Subcutaneous
Measles, combinations with mumps and rubella, live attenuated
Powder, lyophilized, for suspension for reconstitution Subcutaneous or intermuscular
Interventions
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Yellow fever vaccine (live)
Powder and diluent for suspension for injection Subcutaneous
Yellow fever vaccine (live)
Powder and diluent for suspension for injection Subcutaneous
Yellow fever vaccine (live)
Powder and diluent for suspension for injection Subcutaneous
Measles, combinations with mumps and rubella, live attenuated
Powder, lyophilized, for suspension for reconstitution Subcutaneous or intermuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
\* "9 months to 5 years" means from the day of the 9th month after birth to the day before the 6th year birthday
* Aged 11 to 15 months\* on the day of inclusion for participants enrolled in the MMR co-administration group
\* "11 to 15 months" means from the day of the 11th month after birth to the day before the 16th month birthday
* Participants who are healthy as determined by medical evaluation including medical history and physical examination
* For infants\*, born after a gestation period of 27 through 36 weeks and medically stable as assessed by the investigator, based on the following definition: "Medically stable" refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention
\* Infants aged 9 months to 11 months up to the day before the 12th month birthday
* Participant and parent/LAR are able to attend all scheduled visits and to comply with all study procedures
* ICF has been signed and dated by the parent(s) or other LAR (and by an independent witness if required by local regulations)
Exclusion Criteria
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy irradiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* Known history of FV infection
* Known systemic hypersensitivity to any of the study intervention components, eggs or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
* Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
* Chronic illness\* that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion , including malignancy, such as leukemia, or lymphoma
\*Chronic illness may include, but is not limited to, cardiac disorders, renal disorders, auto-immune disorders, diabetes, psychiatric disorders or chronic infection
* History of central nervous system disorder or disease, including seizures and febrile seizures
* Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine in the 4 weeks following the study intervention administration. Vaccine to be administered as part of the National Immunization Schedule will be postponed after the D29 visit
* Previous vaccination against a FV disease at any time including YF with an investigational or marketed vaccine
* Receipt of immune globulins, blood or blood-derived products in the past 6 months
* Administration of any anti-viral within 2 months preceding the study intervention administration and up to the 6 weeks following the study intervention administration
* For participants enrolled in the MMR co-administration group: previous vaccination against measles, measles/mumps/rubella
* For participants enrolled in the MMR co-administration group: history of measles, mumps, rubella confirmed either clinically, serologically, or microbiologically
* Known history or laboratory evidence of HIV infection
* Known history of hepatitis B or hepatitis C seropositivity
* Personal or family history of thymic pathology (thymoma, thymectomy, or myasthenia)
* Participation at the time of study enrollment (or in the 4 weeks preceding the study intervention administration) or planned participation during the first year of the 3-year follow-up in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Enrollment in another study after the first 6 months of follow-up is permitted, assuming it does not exclude participation in this study.
* In an emergency setting, or hospitalized involuntary
* Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
9 Months
5 Years
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Investigational Site Number : 3400001
San Pedro Sula, , Honduras
Investigational Site Number : 3400002
Tegucigalpa, , Honduras
Investigational Site Number : 3400003
Tegucigalpa, , Honduras
Investigational Site Number : 4840007
Torreón, Coahuila, Mexico
Investigational Site Number : 4840013
Cuernavaca, Morelos, Mexico
Investigational Site Number : 4840015
Tizimín, Yucatán, Mexico
Investigational Site Number : 4840009
Chihuahua City, , Mexico
Investigational Site Number : 4840005
Ecatepec, , Mexico
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Related Links
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VYF04 Plain Language Results Summary
Other Identifiers
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VYF04
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1300-4387
Identifier Type: OTHER
Identifier Source: secondary_id
VYF04
Identifier Type: -
Identifier Source: org_study_id
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