Tizimin

Researchers are evaluating the safety and immune response of an investigational yellow fever vaccine called vYF compared to two licensed vaccines, Stamaril and YF-VAX, in children aged from 9 months to 5 years. The study also examines the co-administration of vYF with the Measles Mumps Rubella (MMR) vaccine in infants aged 11 to 15 months. This Phase III study aims to determine how well vYF helps the body develop protective antibodies against yellow fever and to assess its safety profile in these pediatric groups. Eligible participants are divided into two age groups: 9-24 months and 2-5 years. Within each group, children are randomly assigned to receive one dose of vYF, Stamaril, or YF-VAX in a 2:1:1 ratio. Additionally, infants aged 11 to 15 months receive vYF together with a single dose of the MMR vaccine at the same visit. A subset of 120 children from the younger age group who received a yellow fever vaccine will be invited to receive a booster dose approximately three years later. The booster group participants will be followed for an additional six months after the booster administration. Participants will be followed for about three years, with scheduled visits to monitor safety and immune response. Blood samples will be collected to measure the percentage of children who develop antibodies against yellow fever by 28 days after vaccination. Safety evaluations and medical assessments will be conducted throughout the study to monitor any adverse effects. Those in the booster subset will have extended follow-up to assess the response to the booster dose, ensuring comprehensive evaluation of both initial and booster vaccinations.