Kokkola

Researchers are evaluating the effect of the recombinant zoster vaccine on the risk of being newly diagnosed with dementia in adults aged 76 years or older living in Finland. This Phase IV pragmatic trial compares the vaccine to a placebo to understand its impact on dementia incidence in an older adult population. Participants will be followed for up to 10 years to monitor the occurrence of dementia diagnoses, deaths, loss to follow-up, or the end of data availability. Participants are randomly assigned in a 3:1 ratio to receive either the recombinant zoster vaccine or a placebo. Both treatments are given as two intramuscular doses: the first dose at the initial visit (Day 1) and the second dose between 2 and 6 months after the first dose, following the approved dosing schedule. This setup allows researchers to observe and compare the long-term effects of the vaccine versus placebo on new dementia diagnoses. During the study, participants will be monitored through health register data to track dementia diagnosis and related health outcomes. The main measure is the hazard ratio for new dementia diagnoses from the first dose until the earliest of dementia diagnosis, death, loss to follow-up, or study end, with assessments continuing for up to 10 years. Participants must provide informed consent and remain living in the community, as those in nursing facilities are not eligible. Safety and adherence are overseen throughout the study period.

Researchers are evaluating the safety and immune response of a group B streptococcus (GBS) vaccine in healthy pregnant women and their babies in this Phase 3 randomized, placebo-controlled, double-blinded trial. The study includes pregnant women aged 49 or younger between 24 and 36 weeks of gestation with uncomplicated singleton pregnancies and no major fetal abnormalities. Participants must also have documented negative tests for HIV, syphilis, and hepatitis B during this pregnancy. The goal is to learn how the vaccine works and to monitor safety for both mothers and their infants. Participants will receive one injection of either the GBS6 vaccine or a saline placebo. Pregnant women will be followed for up to 14 months, including 6 months after delivery. Their babies will be followed for about 12 months after birth. A subset of infants will also receive routine vaccinations such as diphtheria toxoid-containing vaccines and pneumococcal vaccines according to their country's immunization schedule, with blood samples collected one month after completing primary and toddler booster doses. Mothers will be monitored for local and systemic reactions within 7 days after vaccination, adverse events through 1 month, and serious or medically attended events up to 6 months postpartum. Infants will be observed for adverse events from birth through at least one year, with serious and medically attended events tracked through 6 months. Researchers will also measure antibody levels in infants at birth to assess the vaccine's potential to protect against early and late onset GBS disease. Mothers will attend at least 3 to 4 study visits, some via telephone, to support ongoing safety and immunogenicity assessments.

Researchers are studying whether using oral prednisolone, guided by quick point-of-care testing, helps treat acute wheezing caused by rhinovirus in children aged 6 to 24 months. This study focuses on children diagnosed with wheezing bronchitis who require salbutamol treatment, aiming to better understand treatment options for viral bronchiolitis in this young age group. The trial is a Phase 4 randomized, double-blind, placebo-controlled study designed to assess the effectiveness of this treatment approach. Participants will be randomly assigned to receive either oral prednisolone sodium phosphate suspension at a dose of 1 mg/kg once daily for three days or a placebo sugar syrup suspension in the same volume and schedule. The treatment is given as an oral suspension over a short three-day period following diagnosis and confirmation of rhinovirus or picornavirus infection by point-of-care testing. During the study, researchers will monitor the length of the hospital stay within seven days of study entry as the primary outcome. Participants will be assessed through clinical evaluations including confirmation of viral infection and response to treatment. Safety monitoring and follow-up are conducted during this short period to evaluate the impact of the treatment on the child’s recovery and hospital stay duration.