San Pedro Sula

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.

Researchers are evaluating cancer treatment outcomes in children, adolescents, and young adults aged 0 to 21 years diagnosed with any type of cancer, focusing especially on acute lymphoblastic leukemia and lymphoblastic lymphoma. The study is set in low- and middle-income countries where challenges like delayed diagnosis, misdiagnosis, and limited access to care lead to poorer outcomes compared to high-income countries. This research aims to understand treatment failure and therapy-related toxicities to improve future care strategies. The study collects data by reviewing medical records retrospectively from pediatric, adolescent, and young adult cancer patients treated at oncology centers in Guatemala, Honduras, El Salvador, Armenia, and Tanzania. There are no new drugs or treatments given; instead, the study examines past treatments such as chemotherapy, surgery, radiation therapy, and immunotherapy. Data abstraction is used to assess treatment failure and toxicities over a three-year period from the date of cancer diagnosis. Participants' medical records will be reviewed to gather information on treatment outcomes, therapy-related toxicities, and clinical events within three years following diagnosis. The study monitors the incidence of treatment failure and toxicities by examining available medical records, with patients without events censored at their last contact within three years. This retrospective follow-up helps researchers understand cancer care quality in these settings and supports the development of evidence-based interventions.

Researchers are conducting a phase 3 randomized, modified double-blind study to evaluate three lots of the investigational 21-valent pneumococcal conjugate vaccine (PCV21) in healthy infants aged approximately 2 months. The study aims to compare the immune response, measured by antibody production, and safety of PCV21 to a licensed 20-valent pneumococcal vaccine (Prevnar 201). The goal is to confirm if the different lots of PCV21 produce a similar immune response and assess their safety in infants. Participants will receive four doses of either PCV21 or the licensed 20vPCV vaccine by intramuscular injection at around 2, 4, 6, and 12 months of age. The study includes two groups: Cohort A, which randomizes infants to three PCV21 groups or one 20vPCV comparator group, and Cohort B, which includes randomization to three PCV21 groups only. Routine pediatric vaccinations will also be given according to local recommendations. The study involves six visits over approximately 17 months, spaced between vaccination times and follow-up assessments. Researchers will collect blood samples to measure specific antibody levels 30 days after the third vaccine dose. Participant health will be monitored through medical evaluations and questionnaires. The study will assess vaccine safety and immune response consistency across the vaccine lots during this period.