China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced that it has received approval from the Food and Drug Supervisory Agency of Indonesia to initiate a Phase III clinical study for its Weuphoria, a 13-valent pneumococcal polysaccharide conjugate vaccine.
Study Design and Objectives
The Phase III study is a randomized, blinded, positive-controlled trial designed to assess the immunogenicity and safety of Weuphoria in comparison with Pfizer’s Prevenar 13 and the local Expanded Programme on Immunization (EPI) vaccine. The study will be conducted as a 2p+1 immunization program in healthy infants aged 6 to 8 weeks, aiming to provide comprehensive data on the vaccine’s efficacy and safety profile in this vulnerable population.
Ethical Approvals and Study Enrollment
Prior to this approval, Walvax Bio and its Indonesian partner PT Etana Biotechnologies Indonesia had obtained ethical approvals from all centers involved in the study. The trial is expected to enroll 600 subjects, marking a significant step towards advancing the vaccine’s development and potential registration in Indonesia.-Fineline Info & Tech
