Study to Assess the Safety and Immune Response of the V118E Vaccine in Healthy Adults Aged 18 to 49

What this Trial Is About

Researchers are studying vaccines to prevent illnesses caused by Streptococcus pneumoniae bacteria, which have many different types called serotypes. This trial focuses on a new vaccine called V118E and compares it with an existing vaccine, PREVNAR 20, to learn how safe and well-tolerated V118E is in healthy adults aged 18 to 49. The study is a phase 1 trial designed to evaluate the safety, tolerability, and immune response to V118 formulation E. Participants will receive injections in a two-dose schedule. One group will get the V118E vaccine by intramuscular injection on Day 1 and Day 29. The comparison group will receive one dose of PREVNAR 20 vaccine on Day 1 and a saline injection on Day 29. Both vaccines are given by intramuscular injection, and the study is randomized and double-blind. During the study, participants will be monitored for any side effects, including injection-site reactions and other adverse events up to 12 months after the last vaccination. Researchers will also measure immune responses by checking antibody levels before and after the first vaccination. The study involves regular visits and safety assessments to understand how well participants tolerate the vaccines and to track any medical issues that may arise over the year-long follow-up period.

A Study of V118E in Healthy Participants (V118E-003)