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A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population | Clinical Trials | Clareo Health

RECRUITINGPHASE3

A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population

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

NCT07103148•Sanofi

View on ClinicalTrials.gov

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.

Detailed Description

The duration of each participant's participation will be up to approximately 3 years (not including booster phase in a subset) The Phase III VYF04 is the first study to be carried out with the investigational vYF in pediatric populations.

Eligibility

Age

0 - 5 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Aged 9 months to 5 years on the day of inclusion\*
•\* "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

•Participants are excluded from the study if any of the following criteria apply:
•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
+10 more criteria

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

Key Dates

Start Date

July 11, 2025

Primary Completion Date

August 8, 2026

Completion Date

March 4, 2030

Last Updated

March 10, 2026

Enrollment

2,440

ESTIMATED participants

Conditions

Yellow Fever Immunization

Interventions

Yellow fever vaccine (live)

BIOLOGICAL

Yellow fever vaccine (live)

BIOLOGICAL

Yellow fever vaccine (live)

BIOLOGICAL

Measles, combinations with mumps and rubella, live attenuated

BIOLOGICAL

Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610 Contact-US@sanofi.com

Phase 3 Randomized, Modified Double-blind, Active-controlled Safety Study on vYF in Adults

NCT07002060

Yellow Fever Immunization

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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