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Found 4 Actively Recruiting clinical trials

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Actively Recruiting

Healthy Volunteer

Researchers are evaluating an investigational vaccine called vYF to determine if it is safe and helps the body develop antibodies against yellow fever compared to two licensed vaccines, Stamaril and YF-VAX. The study also looks at how vYF works when given together with the measles, mumps, and rubella MMR vaccine in infants aged 11 to 15 months. This Phase III trial aims to provide important information about the immune response and safety of these vaccines in young children. Eligible children from 9 months to 5 years old will be randomly assigned to receive one dose of either vYF, Stamaril, or YF-VAX vaccine. A special group of infants aged 11 to 15 months will receive vYF together with the MMR vaccine during the same visit. About three years after the first dose, a smaller group of participants aged 9 to 24 months will be invited to receive a booster dose of the vaccine they initially received, followed by an additional 6 months of observation for these participants. Participants will be involved for about three years, during which their immune response will be measured at several time points, including before vaccination, days 11, 15, 29, 6 months, and yearly up to 3 years. Safety will be closely monitored through reports of side effects and medical assessments after each vaccination. Blood samples and other tests will be used to track antibody levels and vaccine effects, helping researchers understand how well the vaccines work and their safety profiles over time.

Age: 9Months - 5YearsAll GendersPhase 3
13 locations
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Actively Recruiting

Healthy Volunteer

This research aims to evaluate the immune response and safety of an investigational chickenpox vaccine VNS Vaccine compared to an already approved vaccine called Varivax VV. The study focuses on healthy children who have not previously had chickenpox or received a chickenpox vaccine, and takes place when the second dose is given three months after the first dose, which is administered between 12 and 15 months of age. Participants are randomly assigned to one of three groups one group receives two doses of the Varivax vaccine another group receives two doses of the investigational VNS vaccine and the third group receives a first dose of Varivax followed by a second dose of the VNS vaccine. Additional vaccines including measles, mumps, and rubella MMR, hepatitis A HAV, and pneumococcal conjugate vaccine PCV are given on the first day. In some countries, a second dose of MMR is also given between 15 and 18 months according to national guidelines. During the study, researchers will monitor immune responses by measuring specific antibodies against the chickenpox virus after the second dose, particularly 43 days post-vaccination. They will also track any local or systemic side effects following each vaccine dose, recording adverse events up to nearly nine months after the first dose. The total participation includes multiple visits over this time, ensuring detailed safety and immune response assessment for each child.

Age: 12Months - 15MonthsAll GendersPhase 3
6 locations
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Actively Recruiting

This research aims to assess cancer treatment outcomes in children, adolescents, and young adults aged 0 to 21 years living in low- and middle-income countries LMICs. It focuses especially on acute lymphoblastic leukemia ALL and lymphoblastic lymphoma LBL, which have poorer outcomes in these regions compared to high-income countries due to challenges like delayed diagnosis, limited access to therapies, and financial barriers. The study seeks to inform future efforts to improve care quality and reduce treatment failures through evidence-based strategies. The study involves a retrospective review of medical records from participating oncology centers in several LMICs, including Guatemala, Honduras, El Salvador, Armenia, and Tanzania. It includes patients with any cancer diagnosis, with particular attention to those diagnosed with ALL or LBL. Researchers will collect data on treatment failure incidence, therapy-related toxicities, and clinical outcomes over a three-year period following cancer diagnosis. No experimental treatments are administered the study uses existing medical records for analysis. Participants medical records will be reviewed to capture information on treatment failure, including relapse, progression, or abandonment, and therapy-related toxicities in the ALLLBL subgroup. Researchers will also analyze outcomes by cancer type, treatment regimen, age, and sociodemographic factors. The primary outcomes include incidence of treatment failure and toxicities within three years of diagnosis. This observational study will provide valuable data to guide improvements in cancer care for young patients in LMICs.

Age: 0Years - 21YearsAll Genders
5 locations
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating the immune response and safety of three different lots of an investigational 21-valent pneumococcal conjugate vaccine PCV21 compared to a licensed 20-valent pneumococcal vaccine 20vPCV, Prevnar 201d in healthy infants aged approximately 2 months. This phase 3 randomized, modified double-blind study aims to determine if the immune responses generated by the three PCV21 lots are similar and safe in this young population. Participants will receive four doses of either one of the three PCV21 vaccine lots or the 20vPCV licensed vaccine at approximately 2, 4, 6, and 12 months of age. Doses are given by intramuscular injection and administered alongside routine pediatric vaccines as per local guidelines. Two cohorts are involved Cohort A includes randomization to three PCV21 groups or the 20vPCV comparator group, while Cohort B includes randomization only to the three PCV21 groups. During the study, participants will attend six visits spaced over the first year of life, with the last visit occurring about 30 days after the 12-month vaccine dose. Researchers will measure antibody levels IgG 30 days after the third vaccine dose to assess immune response. Safety is monitored through observation of adverse events immediately after vaccination and for up to six months after the last dose. The total participation duration per infant is approximately 17 months.

Age: 42Days - 89DaysAll GendersPhase 3
19 locations