Vaxcyte advances VAX-31 infant Phase 2 study

Vaxcyte (PCVX) announced advancement of the modified VAX-31 infant Phase 2 randomized, dose-finding study to the third and final stage. This study is evaluating the safety, tolerability and immunogenicity of VAX-31, a 31-valent pneumococcal conjugate vaccine, PCV, candidate designed to prevent invasive pneumococcal disease, IPD, compared to today’s standard-of-care, Prevnar 20, in healthy infants. The study advanced to the third and final stage following modifications to the protocol to add a new dose arm to evaluate the VAX-31 Optimized Dose and discontinue enrollment in the Low Dose arm. The Middle and High Dose arms are continuing as planned. The randomized, double-blind, active-controlled, dose-finding study will enroll approximately 900 total participants. The Company intends to deliver topline safety, tolerability and immunogenicity data from the primary immunization series and the booster dose either sequentially or together by the end of the first half of 2027.