Kokkola

Researchers are evaluating the effect of the recombinant zoster vaccine on the risk of developing new dementia diagnoses among adults aged 76 years or older living in Finland. This phase IV pragmatic trial aims to assess whether receiving this vaccine influences the incidence of dementia, including Alzheimers disease, over a long follow-up period. Participants will be randomly assigned to receive either the vaccine or a placebo. Participants in the vaccine group receive two doses of the recombinant zoster vaccine the first dose on Day 1 and the second dose between 2 and 6 months later, following the approved dosing schedule. Those in the placebo group receive two doses of placebo injections on the same schedule. The study is randomized, placebo-controlled, and observer-blind to compare outcomes between these two groups. During the study, participants will be followed for up to 10 years after their first dose to monitor for new dementia diagnoses, death, or loss to follow-up. Researchers will use health register data to assess outcomes including new diagnoses of dementia and Alzheimers disease. Safety monitoring includes exclusion of severely immunocompromised individuals and those living in nursing facilities. The total participation duration allows long-term observation of vaccine effects on dementia risk.

The BEATRIX study focuses on healthy pregnant women aged 49 or younger between 24 and 36 weeks of pregnancy to evaluate the safety and immune response of a group B streptococcus GBS vaccine. Researchers aim to understand how this vaccine works in pregnant women and their babies, assessing various safety measures and immune responses related to GBS. This study is a Phase 3, randomized, placebo-controlled, double-blinded trial sponsored by Pfizer. Participants will receive a single injection of either the GBS vaccine or a placebo saline. After birth, a subset of infants will receive routine vaccines according to each countrys immunization schedule, including vaccines for diphtheria, pneumococcal disease, and others. Some infants will have blood samples taken after completing their primary and toddler vaccine doses to evaluate immune responses. Pregnant participants will visit the study site at least three to four times, with some visits possibly conducted by phone, and may stay involved for up to 14 months, including six months after delivery. Their babies will be followed for about 12 months, with a subset participating for up to 19 months. Researchers will monitor local and systemic reactions, adverse events, and antibody levels in both mothers and infants to assess safety and immunogenicity of the vaccine throughout the study period.

Researchers are evaluating whether giving oral prednisolone based on quick point-of-care test results can help treat sudden wheezing caused by rhinovirus in children aged 6 to 24 months. This randomized, double-blind, placebo-controlled Phase 4 trial focuses on acute viral bronchiolitis in young children who require salbutamol treatment and have a confirmed rhinovirus or picornavirus infection. The study aims to understand if targeted treatment can improve recovery and reduce hospital stay. Participants are randomly assigned to receive either prednisolone sodium phosphate oral suspension or a sugar syrup placebo. The prednisolone dose is 1 mgkg once daily for three days, with a maximum of 20 mg per dose adjusted by weight. The placebo is given in the same volume and schedule to match the active treatment. The study uses triple masking to keep patients, caregivers, and researchers unaware of the treatment allocation. During the study, children will be monitored for several outcomes including length of hospital stay, need for intensive care, oxygen use, symptom scores, recurrence of wheezing, cough duration, and use of asthma medications. Assessments occur within days to months after study entry, with follow-up up to 24 months. Safety and treatment effects are closely observed through hospital records and symptom tracking, with the primary outcome focusing on hospital stay length within 7 days of starting treatment.