Site Initiation Visit (SIV) – Bivalent Typhoid Vaccine Clinical Trial at BGS Medical College & Hospital, Nagaruru
The Department of Pediatrics at BGS MCH, in strategic collaboration with the Department of Clinical Pharmacology, successfully convened a comprehensive Site Initiation Visit for the upcoming Bivalent Typhoid Vaccine Clinical Trial. Held across two days from June 23 to June 24, 2026, at the MEU Hall, the event marked the formal launch of a critical research initiative sponsored by the Serum Institute of India Private Limited. This clinical trial focuses on the evaluation of a bivalent vaccine designed to offer dual protection against both Salmonella Typhi and Salmonella Paratyphi A, addressing a significant public health challenge in the prevention of enteric fever.
The study is spearheaded by Dr. Ramesh M, Professor and Head of the Department of Pediatrics, who serves as the Principal Investigator. He is supported by a distinguished team of Co-Investigators including Dr. Aditi G, Dr. Srushty S, and Dr. Shagufta Parveen. The initiation visit also saw active participation from the Department of Clinical Pharmacology, represented by Dr. Malini, Professor and Head, alongside Dr. Suresh and Dr. Dwajini. The collaborative nature of the project was further emphasized by the inclusion of a multidisciplinary team comprising pharmacists, laboratory technicians, staff nurses, and clinical research coordinators, organized into specialized blind and non-blind operational teams.
Expert trainers from the Serum Institute of India Private Limited, Dr. Sanketh Gaidhani and Mr. Balachander, facilitated the sessions alongside a robust clinical operations team from Emmes. The two-day program provided investigative personnel with intensive training on the clinical trial protocol and the rigorous standards of Good Clinical Practice. Detailed modules covered essential aspects such as informed consent procedures, participant safety protocols, investigational product management, and sophisticated data management systems. Every facet of the trial operations, from laboratory procedures to documentation and ethical regulatory requirements, was meticulously reviewed to ensure the highest standards of scientific integrity.
The visit also involved a thorough inspection of the site readiness, including a review of essential documents and the preparedness of the pharmacy and laboratory facilities. The successful conclusion of this initiation visit signifies the formal activation of the study site. With all operational and ethical frameworks firmly in place, the institution reflects its readiness to commence participant enrollment in strict accordance with approved protocols. This milestone underscores the commitment of the Department of Pediatrics and the Department of Clinical Pharmacology to advancing medical science and contributing to global health through high-quality evidence-based research.
