Simpsonville

Researchers are evaluating the consistency of immune responses to three different batches of an investigational chickenpox vaccine called VNS vaccine in healthy children aged 12 to 15 months who have not had chickenpox or received a chickenpox vaccine before. The study also compares the safety and immune response of the VNS vaccine to an approved chickenpox vaccine known as Varivax. This Phase 3a study is sponsored by GlaxoSmithKline and aims to better understand the immune protection provided by these vaccines. Participants are randomly assigned to receive one dose of either one of the three investigational VNS vaccine lots or one of two lots of the marketed Varivax vaccine. Along with the chickenpox vaccine, they also receive one dose each of measles, mumps, and rubella MMR vaccine, hepatitis A vaccine HAV, and a pneumococcal conjugate vaccine PCV which could be PCV 13, Vaxneuvance, or PCV 20 depending on availability and country recommendations. All vaccines are given on Day 1 of the study. During the study, researchers monitor the participants immune responses by measuring antibodies against varicella zoster virus VZV and other vaccine components at Day 43. They also track safety by recording any side effects or adverse events from Day 1 to Day 181. The study includes diary reports by parents and regular clinical evaluations to assess immune response and safety outcomes. Participation involves a single vaccination visit and follow-up assessments over approximately six months.

Researchers are evaluating the immune response and safety of an investigational combined measles, mumps, rubella, and varicella vaccine MMRVNS compared to the already licensed MMRV vaccine ProQuad. The study focuses on healthy children aged 15 months to 6 years who have previously received a first dose of any measles, mumps, rubella, and varicella-containing vaccine. This Phase 3a, randomized, observer-blind trial aims to assess prevention by comparing these two vaccines when given as a second dose intramuscularly. Participants receive a single intramuscular dose of either the investigational MMRVNS vaccine or the licensed MMRV vaccine on Day 1. The study uses a parallel design with two groups one receiving MMRVNS and the other receiving MMRV. The vaccines are administered as a second dose to children previously vaccinated according to their countrys immunization schedule. The study monitors participants closely for immune response and safety after vaccination. Throughout the study, children undergo assessments including blood tests to measure Immunoglobulin G IgG responses against measles, mumps, rubella, and varicella at Day 43. Safety evaluations include monitoring for injection site reactions, systemic events, and adverse events up to 181 days after vaccination. The study tracks solicited and unsolicited adverse events and serious adverse events to understand the safety profile. Participation lasts until study completion, with multiple follow-up periods to ensure thorough monitoring.

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.

This research aims to find out if NNC0487-0111 is safe and effective for adults with excess body weight. The study compares this medicine to a placebo in people who have a history of unsuccessful attempts to lose weight through diet. It is a phase 3 clinical trial that evaluates treatment for obesity, focusing on weight loss and related health measures. Participants receive weekly injections under the skin with either NNC0487-0111 at one of four dose levels or a placebo. These injections are given using pre-filled pen-injectors to the thigh, abdomen, or upper arm. All participants follow a reduced-calorie diet and increase physical activity during the study. The trial lasts up to 136 weeks, with treatment and follow-up periods designed to assess long-term effects. Throughout the study, participants attend regular visits where researchers measure changes in body weight, waist circumference, blood pressure, blood sugar levels, cholesterol, and quality of life scores. Safety is monitored by tracking any adverse events during and after treatment. The main outcome is the relative change in body weight from the start of the study to week 84, with continued observation up to week 136. Participants remain under medical supervision throughout the trial.

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 the immune response and safety of three different lots of an investigational 21-valent pneumococcal conjugate vaccine PCV21 compared to a licensed 20-valent pneumococcal vaccine 20vPCV, Prevnar 201d in healthy infants aged approximately 2 months. This phase 3 randomized, modified double-blind study aims to determine if the immune responses generated by the three PCV21 lots are similar and safe in this young population. Participants will receive four doses of either one of the three PCV21 vaccine lots or the 20vPCV licensed vaccine at approximately 2, 4, 6, and 12 months of age. Doses are given by intramuscular injection and administered alongside routine pediatric vaccines as per local guidelines. Two cohorts are involved Cohort A includes randomization to three PCV21 groups or the 20vPCV comparator group, while Cohort B includes randomization only to the three PCV21 groups. During the study, participants will attend six visits spaced over the first year of life, with the last visit occurring about 30 days after the 12-month vaccine dose. Researchers will measure antibody levels IgG 30 days after the third vaccine dose to assess immune response. Safety is monitored through observation of adverse events immediately after vaccination and for up to six months after the last dose. The total participation duration per infant is approximately 17 months.

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.