Condition: Yellow Fever Immunization · Sponsor: Sanofi
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…
This description comes directly from the study's public registry record.
Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · Contact-US@sanofi.com
Always discuss trial participation with your own doctor first.
| Investigational Site Number : 3400001 | San Pedro Sula, Honduras | Recruiting |
| Investigational Site Number : 3400005 | San Pedro Sula, Cortes, Honduras | Recruiting |
| Investigational Site Number : 3400002 | Tegucigalpa, Honduras | Recruiting |
| Investigational Site Number : 3400003 | Tegucigalpa, Honduras | Recruiting |
| Investigational Site Number : 3400007 | Tegucigalpa, Honduras | Recruiting |
| Investigational Site Number : 4840007 | Torreón, Coahuila, Mexico | Recruiting |
| Investigational Site Number : 4840013 | Cuernavaca, Morelos, Mexico | Recruiting |
| Investigational Site Number : 4840015 | Tizimín, Yucatán, Mexico | Recruiting |
| Investigational Site Number : 4840009 | Chihuahua City, Mexico | Recruiting |
| Investigational Site Number : 4840005 | Ecatepec de Morelos, Mexico | Recruiting |
| Investigational Site Number : 5910001 | Panama City, Panama | Recruiting |
| Investigational Site Number : 5910002 | Panama City, Panama | Recruiting |
+ 1 more locations — full list on the registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07103148