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A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population
Led by Sanofi · Updated on 2026-05-06
2440
Participants Needed
13
Research Sites
242 weeks
Total Duration
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AI-Summary
What this Trial Is About
The purpose of this study is to determine whether vYF (investigational vaccine) is safe and can help the body to develop antibodies (immunogenicity) compared with Stamaril vaccine and YF-VAX vaccine (both licensed vaccines) and when they are co-administered with Measles Mumps Rubella (MMR) vaccines in infants aged 11-15 months. 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.
CONDITIONS
Official Title
A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 9 months to 5 years on the day of inclusion
- Aged 11 to 15 months on the day of inclusion for MMR co-administration group
- Healthy as confirmed by medical history and physical exam
- Infants born after 27 to 36 weeks of gestation and medically stable if aged 9 to 11 months
- Participant and parent/LAR able to attend all visits and follow study procedures
- Signed informed consent by parent(s) or legal representative
You will not qualify if you...
- Known or suspected immunodeficiency or recent immunosuppressive therapy
- History of yellow fever virus infection
- Allergy to study vaccine components, eggs, or serious reaction to similar vaccines
- Moderate or severe illness or fever (≥38.0°C) on vaccination day
- Chronic illness that may interfere with study, including cancer
- History of central nervous system disorders or seizures
- Vaccination within 4 weeks before or planned within 4 weeks after study vaccine
- Previous yellow fever vaccination at any time
- Recent immune globulin, blood products, or antiviral treatment
- For MMR group: prior vaccination or confirmed infection with measles, mumps, or rubella
- Known HIV, hepatitis B or C infection
- Personal or family history of thymic disease
- Participation in another clinical study within 4 weeks before or planned in first year
- Hospitalized involuntarily or in emergency setting
- Child of investigator or study staff involved in the trial
AI-Screening
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Trial Site Locations
Total: 13 locations
1
Investigational Site Number : 3400001
San Pedro Sula, Honduras, 21104
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2
Investigational Site Number : 3400005
San Pedro Sula, Cortes, Honduras, 21104
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3
Investigational Site Number : 3400002
Tegucigalpa, Honduras, 11101
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4
Investigational Site Number : 3400003
Tegucigalpa, Honduras, 11101
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5
Investigational Site Number : 3400007
Tegucigalpa, Honduras, 11101
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6
Investigational Site Number : 4840007
Torreón, Coahuila, Mexico, 27000
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7
Investigational Site Number : 4840013
Cuernavaca, Morelos, Mexico, 62290
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8
Investigational Site Number : 4840015
Tizimín, Yucatán, Mexico, 97700
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9
Investigational Site Number : 4840009
Chihuahua City, Mexico, 31000
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10
Investigational Site Number : 4840005
Ecatepec de Morelos, Mexico, 55075
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11
Investigational Site Number : 5910001
Panama City, Panama, 10662
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12
Investigational Site Number : 5910002
Panama City, Panama, 10662
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13
Investigational Site Number : 5910003
Panama City, Panama, 10662
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Research Team
T
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CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
7
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