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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Healthy Volunteer

Researchers are evaluating the safety and immune response of a second dose of the RSVpreF vaccine in pregnant women during later pregnancies. The study also aims to understand how long the protection lasts from a single dose given during a previous pregnancy by examining blood samples from nonpregnant participants who had the vaccine before. This Phase 3 trial involves pregnant participants and their unborn babies, as well as nonpregnant participants previously vaccinated. Pregnant participants are divided into two groups one group who previously received RSVpreF in a Pfizer trial will get a second dose, and another group will be randomly assigned to receive either RSVpreF or a placebo if no prior antibody data exists. Infants born to these participants will be followed for six months to monitor safety and antibody levels. Nonpregnant participants who received RSVpreF in an earlier trial will provide blood samples to assess the durability of their immune response without receiving additional vaccine doses. Participants will undergo safety monitoring including tracking local and systemic reactions, adverse events, and serious events during pregnancy and after birth for infants. Blood tests will measure neutralizing antibodies against RSV types A and B at birth, 3 months, and 6 months. The study includes consent procedures for both pregnant participants and infants, and nonpregnant participants will have scheduled visits for blood sample collection. The total study duration extends through infant follow-up and ongoing immune response assessments.

Age: 0Years +All GendersPhase 3
97 locations
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating the safety, reactogenicity, and immune response of the GlaxoSmithKline Biologicals SA GSK Vaccines Institute for Global Health GVGH invasive nontyphoidal Salmonella-typhoid conjugate iNTS-TCV vaccine in infants. The study focuses on administering the first dose either at 6 months of age or at 6 weeks of age. This Phase 2a trial aims to find the appropriate dose and schedule for the vaccine to protect against invasive nontyphoidal Salmonella disease and typhoid fever in infants in Africa. The study involves multiple groups of infants receiving different vaccine schedules and doses. Infants aged 6 months receive three doses of either a low or full dose of iNTS-TCV vaccine on Day 1, Day 85, and Day 337, or combinations of other vaccines including TYPHIBEV, Prevenar 13, and Nimenrix. Infants aged 6 weeks receive similar dosing schedules but with adjusted timing at Day 1, Day 57, and Day 232, including some groups receiving saline doses. The study includes control groups receiving licensed vaccines for comparison. Participants will be closely monitored throughout the study for side effects at the injection site and systemically, with assessments occurring within 7 days after each vaccine dose. Safety monitoring continues for up to 505 days for infants starting at 6 months and 400 days for those starting at 6 weeks. Blood tests will measure immune responses before and after vaccinations, evaluating antibodies against Salmonella and typhoid antigens. The study includes detailed laboratory assessments and tracking of any adverse events or serious complications during the follow-up period.

Age: 6Weeks - 6MonthsAll GendersPhase 2
1 location
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Actively Recruiting

Healthy Volunteer

Researchers are studying the persistence of immune response to the NmCV-5 vaccine, a pentavalent meningococcal ACYWX conjugate vaccine, in participants aged 2 to 29 years from Mali and The Gambia. The goal is to understand how long the antibody protection lasts more than five years after a single dose vaccination and whether a booster dose might be needed in this population. This observational long-term follow-up study involves contacting 1800 former participants from an earlier study by phone, followed by an in-person visit for a randomly selected subset of 450 participants. The study focuses on evaluating antibody levels against meningococcal serogroups A, C, Y, W, and X more than five years post-vaccination, measuring geometric mean titers and percentages of participants with specific antibody titers. Participants will be involved in a telephone interview and a clinical visit for blood sampling to assess antibody levels. Researchers will measure immune response persistence using serum bactericidal antibody titers. The study will monitor these immune markers to help determine the duration of vaccine-induced protection. Participation will last beyond five years after the initial vaccination, with safety and compliance monitored throughout.

Age: 7Years - 36YearsAll Genders
2 locations