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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the safety, tolerability, and immune response duration of a second dose of the RSVpreF vaccine given during later pregnancies. The study also examines how long immunity lasts from a single dose given during a previous pregnancy by analyzing blood samples from nonpregnant participants who had the vaccine before. This is a Phase 3 trial focused on pregnant women and their babies as well as nonpregnant women previously vaccinated. Pregnant participants are grouped into Cohort 1, who previously received RSVpreF in a Pfizer trial and will get a second dose, and Cohort 2, who received RSVpreF previously via commercial or trial means and will be randomly given either RSVpreF or placebo. Both groups will be monitored for safety and immune response. Cohort 3 includes nonpregnant women who had RSVpreF before and will provide blood samples to check how long protection lasts, without receiving further vaccination. Participants will undergo safety monitoring during pregnancy and after birth. Infants will be followed for six months to assess safety and antibody levels. Blood tests will measure immune response, including neutralizing antibodies at birth. The study tracks local and systemic reactions, adverse events, serious adverse events, and new medical conditions in both pregnant participants and their infants over various timeframes throughout the study.
Actively Recruiting
Healthy Volunteer
This research aims to assess the safety, side effects, and immune response caused by the GlaxoSmithKline Biologicals SA Vaccines Institute for Global Health invasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) in infants. The study focuses on two groups of infants: those receiving their first dose at 6 months of age and those at 6 weeks of age. It evaluates how the vaccine works against invasive nontyphoidal Salmonella infections and typhoid fever. Participants will receive different doses of the iNTS-TCV vaccine, including low and full doses. Additional vaccines such as TYPHIBEV, Prevenar 13, and Nimenrix, as well as saline, may also be administered as part of the study. The study includes an age de-escalation approach and is conducted at a single center. Vaccinations are given according to specific schedules depending on the infant's age group. During the study, infants will be closely monitored for any side effects at the injection site and systemic reactions within seven days after each vaccination dose. Researchers will also track any adverse or serious adverse events for up to 28 days or longer following vaccination. Laboratory tests will be performed to check for abnormalities after each dose. The immune response will be measured by antibody levels at specific times after vaccination. The total study duration is up to 505 days for some participants, ensuring thorough safety and immune response evaluations.