A Phase 1, Observer-Blind, Randomized, Active Controlled Trial to Evaluate the Safety and Immunogenicity of an Investigational Pneumococcal Vaccine in Adults 50 To 64 Years of Age
This study will evaluate the safety and immune response of a new formulation of pneumococcal vaccine, PnMAPS30plus, in healthy adults aged 50 to 64 years. Participants will receive a single dose of either the investigational vaccine or an approved pneumococcal vaccine (PCV20) and will be monitored for approximately six months. The study aims to determine if PnMAPS30plus is safe and well-tolerated and whether it helps the body produce antibodies that protect against pneumococcal disease.
• Participants who, in the opinion of the investigator, can comply with the requirements (e.g., completion of the electronic diary \[eDiary\], return for follow-up visits).
• Written or witnessed/thumb printed informed consent obtained before any trial-specific procedure.
• Healthy or medically stable adults confirmed by medical history and clinical examination at screening. Participants with stable medical conditions can be enrolled at the discretion of the investigator.
• Male and female participants aged 50 and 64 years of age (YOA) at the time of Informed consent form (ICF) signature.
• Female participants of childbearing potential (POCBP) may enrol if they practice adequate contraception and have a negative pregnancy test prior to study intervention administration.