South Euclid

Researchers are studying an investigational vaccine designed to protect healthy adults against Escherichia coli E coli. This Phase 1 clinical trial aims primarily to assess the safety and tolerability of several candidate E coli vaccines administered intramuscularly. The study involves healthy adults aged 18 to 64 years without serious medical conditions. Participants will be randomly assigned to receive one of several experimental E coli vaccine doses or a placebo. Each participant receives injections on day 1 and day 180, following a 0 and 6-month schedule. The study is double-blinded, meaning neither the participants nor the investigators know who receives the vaccine or placebo during the trial. During the study, participants will be monitored closely for local and systemic reactions within 7 days after each vaccination. Researchers will also track adverse events from the first vaccination through 12 months after the last dose. Safety assessments include medical exams and recording any serious or medically attended health issues. The total participation lasts up to 18 months with regular visits and safety follow-up.

Researchers are evaluating the safety and immune response of a new multivalent pneumococcal vaccine called PG4 compared to the currently used 20-valent pneumococcal conjugate vaccine 20vPnC in healthy infants. The study aims to understand how well the new vaccine helps fight germs causing pneumonia, meningitis, and ear infections. This phase 3 trial involves infants aged 2 to 6 months and seeks to determine if the new vaccine is as safe as the existing one while assessing its immune response when given alongside other childhood vaccines. Participants are divided into three groups based on age and location. Group 1 includes about 3000 infants aged 2 months who receive either PG4 or 20vPnC by injection into the left thigh muscle at ages 2, 4, 6, and 12 to 15 months. Groups 2 and 3, with about 230 infants outside the United States aged 2 to 6 months, receive vaccinations on a slightly different schedule, with Group 3 exploring both intramuscular and subcutaneous administration of PG4. Participants have a randomized chance of receiving one of the study vaccines. During the study, infants will attend six clinic visits and one phone call where parents report any side effects. Blood samples will be collected three times to assess the immune response by measuring proteins that fight the germs. Researchers will track local and systemic reactions, adverse events, and serious adverse events throughout the study period, which lasts about 1 to 1.5 years depending on the group. The study monitors safety closely to compare the new vaccines effects with the current standard vaccine.

Researchers are evaluating the safety and tolerability of a new multivalent pneumococcal vaccine called PG4 compared to the currently used 20-valent pneumococcal conjugate vaccine 20vPnC in healthy infants about 2 months old. The study aims to see if the new vaccine is as safe as the existing one and whether it can provide additional protection against infections caused by the Streptococcus pneumoniae germ, including pneumonia, meningitis, and ear infections. This is a phase 3, randomized, double-blinded trial conducted by Pfizer focused on prevention of pneumococcal disease. About 2400 infants will be randomly assigned to receive either the PG4 vaccine or the 20vPnC vaccine. Vaccinations are given by injection into the left thigh muscle at 2, 4, 6, and between 12 to 15 months of age. The study consists of two groups receiving these vaccines according to this schedule. The treatment period spans these vaccination times, with a total participation duration of about 16 to 19 months. During the study, infants will have six clinic visits and one phone call for monitoring. Parents or legal guardians will report any side effects or adverse events their infant experiences after vaccinations. Researchers will evaluate local and systemic reactions within 7 days of each dose, adverse events from the first dose through one month after the third and fourth doses, and serious adverse events up to six months after the last dose. Safety and tolerability data will be collected throughout the study period.

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 comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

This research aims to evaluate the safety and immune response of a new pneumococcal vaccine called PG4 in children and adolescents aged 15 months to 18 years. It compares this new vaccine to the currently used 20-valent pneumococcal conjugate vaccine 20vPnC, focusing on how both vaccines help protect against infections like pneumonia, meningitis, and ear infections caused by Streptococcus pneumoniae. The study is a phase 3 trial conducted internationally, including the United States and Puerto Rico. Participants are divided into three age groups 15 months to less than 2 years, 2 years to less than 5 years, and 5 years to less than 18 years. Within each group, participants are randomly assigned in a 21 ratio to receive a single injection of either the new PG4 vaccine or the 20vPnC vaccine. The vaccine is administered intramuscularly in the arm or thigh. The study lasts about 6 months and involves 2 clinic visits and 1 telephone follow-up. During the clinic visits, blood samples are taken to measure immune responses and participants are monitored for any side effects or adverse events. Researchers assess local and systemic reactions within 7 days after vaccination, adverse events up to 1 month, and serious adverse events up to 6 months after vaccination. The main outcomes include measuring specific antibody levels to evaluate the immune response. Participants are contacted by phone for a follow-up to check for any further side effects, ensuring ongoing safety monitoring throughout the study.