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A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population
Sponsor: Sanofi
Summary
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.
Official title: A Parallel Group, Phase III Randomized, Modified Double-blind, Active Controlled Study to Investigate the Immunogenicity and Safety of vYF Compared to Licensed YF Vaccines in Pediatric Population Aged 9 Months to 5 Years of Age
Key Details
Gender
All
Age Range
9 Months - 5 Years
Study Type
INTERVENTIONAL
Enrollment
2440
Start Date
2025-07-11
Completion Date
2030-03-04
Last Updated
2026-03-10
Healthy Volunteers
Yes
Conditions
Interventions
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
Locations (9)
Investigational Site Number : 3400001
San Pedro Sula, Honduras
Investigational Site Number : 3400002
Tegucigalpa, Honduras
Investigational Site Number : 3400003
Tegucigalpa, Honduras
Investigational Site Number : 3400007
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 de Morelos, Mexico