Exciting Development: PCV Vaccine Clinical Trial Underway at Local Health Centers

In a significant milestone for medical research, a clinical trial focusing on the Pneumococcal Conjugate Vaccine (PCV), also known as the PCV13-004 STUDY, has successfully recruited and enrolled 161 subjects per 1 April 2024 among the total target of 300 subjects. Spearheaded by Dr. I Gusti Ayu Trisna Windiani, Sp.A (K), a distinguished faculty member specializing in child and community health, along with lecturers and alumni from the Master's Program of Public Health at Udayana University's Faculty of Medicine, this study marks a crucial step in effort to develop vaccine for combating infectious diseases among children.

Ensuring the highest standards of quality, international sponsorship from Walvax Biotechnology Co. LTD has initiated monitoring and evaluation activities from April 1st to 5th, 2024. Prodia the CRO, serving as the Clinical Research Organizer (CRO) for the PCV13-004 study, is actively involved in this process. The focus of monitoring lies in addressing queries concerning enrolled subjects, preparing for impending visits from the Data Safety Monitoring Board (DSMB) scheduled for the end of April 2024. Such rigorous oversight guarantees the integrity of the study's execution while prioritizing the safety and well-being of its participants.

This research collaboration represents a significant stride in advancing the internationalization agenda of Udayana University's Faculty of Medicine and underscores its commitment to excellence as articulated in its vision and mission. Moreover, by engaging local health centers in globally standardized research activities, this initiative indirectly enhances the competencies of the Master's Program, its alumni, and health center personnel in adhering to rigorous clinical trial protocols. Additionally, it showcases the Faculty of Medicine's dedication to community service by bolstering human resources and infrastructure essential for research endeavors within local health centers.

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