Fall River

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 safety and effectiveness of Armour Thyroid compared to synthetic T4 in adults with primary hypothyroidism who have been stable on synthetic T4 treatment. The study will also assess how well patients tolerate switching from synthetic T4 to Armour Thyroid. This trial is a Phase 23, randomized, double-blind study sponsored by AbbVie to compare these two thyroid hormone replacement therapies. Participants will be randomly assigned to receive either Armour Thyroid or to alternate between Armour Thyroid and synthetic T4 for up to 81 weeks. The treatments are oral capsules or tablets taken daily, with doses carefully converted from their stable synthetic T4 dose. The study includes a dose-conversion period where dosage adjustments may be made to maintain appropriate thyroid hormone levels. During the study, participants will have regular blood tests to measure thyroid-stimulating hormone TSH levels, including at week 55 to see who achieves a target TSH response. Researchers will also monitor for any adverse events throughout the study, which lasts up to about 90 weeks. Dose adjustments and safety data will be tracked closely to understand treatment effects and tolerability over time.

This research aims to evaluate the long-term safety and explore the efficacy of astegolimab in adults aged 40 to 90 years with chronic obstructive pulmonary disease COPD. It focuses on participants who have completed a 52-week placebo-controlled treatment period in previous studies GB43311 or GB44332. The study is a phase 3, open-label extension to gather extended safety information on this drug in COPD patients. Participants from the parent studies who qualify will receive subcutaneous injections of astegolimab every two weeks throughout the study until it ends. This open-label extension allows all participants to receive the active drug without placebo comparison. The study continues treatment beyond the initial 52-week period to monitor long-term effects. During the study, participants will be monitored for adverse events up to 12 weeks after their last dose of astegolimab. Researchers will collect safety data to understand the incidence of any side effects. The study involves regular assessments and follow-ups to ensure participant well-being, with the total duration lasting until July 2034.

Researchers are studying the investigational drug GB-0895 as an additional treatment for adolescents and adults aged 12 to 80 years with severe asthma that is not controlled by inhaled corticosteroids and other standard asthma treatments. This Phase 3, randomized, double-blind, placebo-controlled trial aims to evaluate the safety and effectiveness of GB-0895 in improving asthma control over a year. The trial includes an optional open-label extension for further assessment. Participants will be randomly assigned to receive either GB-0895 or a placebo by subcutaneous injection every six months during the 52-week treatment period. The study also includes a screening and baseline phase, a run-in phase before treatment, and a follow-up period after treatment ends. During the optional extension phase, participants may continue receiving GB-0895 at specified time points. The study involves multiple visits approximately every 1 to 2 months after the first month. Throughout the trial, participants will undergo various assessments including lung function tests, asthma symptom diaries, quality of life questionnaires, and monitoring of asthma exacerbations. Researchers will track annual asthma exacerbation rates and changes in asthma control and quality of life scores. Safety will be closely monitored during and after treatment. Total participation may last up to about 2.7 years if including the extension phase.

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.

Researchers are studying the effects and safety of the medicine PF-07275315 for adults aged 35 to 80 with moderate to severe chronic obstructive pulmonary disease COPD. COPD makes breathing difficult and reduces quality of life. This clinical trial aims to evaluate PF-07275315 compared to placebo to assess its potential as a treatment for COPD. Participants will receive either multiple injections of PF-07275315 or placebo shots in a clinic over 24 weeks for the Phase 2 part and 52 weeks for the Phase 3 part. The study uses a randomized and parallel design to compare outcomes between the groups. Phase 2 participants will have 11 clinic visits over about 40 weeks, while Phase 3 participants will have 18 visits over about 68 weeks. During the trial, participants will undergo lung function tests including forced expiratory volume FEV1 measurements, and assessments of COPD exacerbations. Researchers will monitor safety, adverse events, and changes in respiratory symptoms and quality of life. The study includes regular clinic visits for treatment and evaluations, with the total duration depending on the phase of participation.

This clinical trial studies adults with opioid use disorder who are in outpatient treatment and receiving buprenorphine or methadone maintenance therapy. The research aims to find out if semaglutide, a glucagon-like peptide-1 receptor GLP-1R agonist, can reduce the use of illicit and nonprescribed opioids compared to a placebo. The study is a phase 2, randomized, and quadruple-blinded trial designed to evaluate treatment effects over several weeks. Participants will be randomly assigned to receive either semaglutide or a placebo via a weekly subcutaneous injection for 12 weeks. The semaglutide dose starts low at 0.25 mg and is gradually increased up to 1.0 mg weekly based on tolerance. After the 12-week intervention, there is a 1-week washout period without treatment, followed by a final follow-up visit about 4 weeks later. The placebo group receives a dry needle stick weekly without any drug. Throughout the study, participants visit the clinic weekly for urine drug screening, pregnancy tests, vital sign checks, and to complete mental health and drug use questionnaires. They also complete smartphone surveys during the study. Blood samples are collected twice, and a physical exam with medical history is done at baseline. Researchers measure abstinence from illicit opioids weekly during treatment and assess opioid cravings and stimulant use as secondary outcomes. Participation lasts about 19 weeks in total.

This research evaluates the safety and performance of the Sphere-360 Pulsed Field Ablation Catheter combined with the Affera Mapping and Ablation System for treating people with paroxysmal atrial fibrillation PAF. It is a prospective, single-arm clinical study conducted across multiple sites in the United States. The goal is to analyze key outcomes including freedom from atrial tachyarrhythmia recurrence and any serious device- or procedure-related adverse events. Participants will undergo pulmonary vein isolation ablation using the Sphere-360 catheter and Affera system. This device-based treatment aims to isolate the pulmonary veins to manage PAF symptoms. The study involves a single treatment group and includes follow-up monitoring for up to 12 months after the ablation to assess outcomes. During the study, participants will be evaluated regularly through assessments that monitor their heart rhythm and quality of life. The main outcomes measured include the absence of atrial arrhythmia recurrence for 12 months and the incidence of serious adverse events within 6 months. Quality of life questionnaires will also be completed. The total follow-up period extends for one year after the initial treatment, allowing careful observation of both effectiveness and safety.

This research aims to observe patients with recurrent symptomatic paroxysmal or persistent atrial fibrillation who are undergoing treatment with the PulseSelect PFA System. The study is a prospective, global, multi-center, non-randomized observational trial designed to monitor outcomes after ablation using this approved device. The trial focuses on evaluating freedom from atrial fibrillation at 36 months post-procedure and safety regarding device or procedure-related adverse events at 6 months. Participants will receive ablation treatment with the commercially available PulseSelect PFA System according to standard hospital care. The study includes follow-up visits at 3, 6, 12, 24, and 36 months after ablation. During the 6, 12, 24, and 36 month visits, participants will undergo 24-hour Holter monitoring to track heart rhythm and other relevant cardiac data. Throughout the 36-month follow-up period, participants will attend scheduled study visits for evaluations including heart rhythm monitoring and safety assessments. Researchers will measure treatment effectiveness by assessing freedom from atrial fibrillation and monitor for any device or procedure-related adverse events. The study involves long-term observation to understand outcomes after treatment with the PulseSelect PFA System.

Researchers are evaluating the use of the FARAWAVE and FARAPOINT pulsed field ablation PFA catheters to treat persistent atrial fibrillation PersAF in patients who have had a previous unsuccessful ablation procedure. This prospective, single-arm, open-label, multi-center study aims to assess the safety and effectiveness of re-treating PersAF, including mitral isthmus catheter ablation, using the FARAPULSE PFA System. Participants will undergo repeat ablation with the FARAPULSE PFA System, which includes the FARAWAVE and FARAPOINT catheters. The FARAWAVE Catheter isolates pulmonary veins and the posterior wall, while the FARAPOINT Catheter is used for creating additional ablation lines such as the mitral isthmus. This treatment is delivered as a single-arm intervention without a comparison group. Throughout the study, participants will be monitored for safety and effectiveness outcomes. The primary safety endpoint is assessed within 60 days, while procedural success is evaluated within 24 hours after treatment. Participants must provide informed consent and attend all follow-up visits as scheduled at approved clinical centers. The total study duration extends through primary completion in April 2027 and study completion in January 2028.