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Seamless coordination of complex pediatric Phase III clinical trial for ROTAVAC 5C® in India brings world closer to improving the global supply of affordable rotavirus vaccines.



George Clinical was selected by sponsor Bharat Biotech to conduct a seamless, sequential Phase III, randomized, multi-center, single-blind study to evaluate immunogenicity, safety and reactogenicity of liquid ROTAVAC 5C formulation of the live attenuated rotavirus vaccine as a 3-dose series when compared with ROTAVAC 5C in infants. Highly contagious rotaviruses are the leading cause of severe diarrheal illnesses among infants and young children in both developed and resource-limited countries. Each year, rotavirus induced diarrheal disease kills roughly 213,000 children younger than 5 years old and hospitalizes an estimated two million children worldwide, largely in developing countries. The youngest children—those between 6 months and 2 years of age—are most vulnerable.

ROTAVAC (based on the 116E strain) became the first indigenously developed vaccine from India to be prequalified by World Health Organization (WHO), thus allowing the vaccine to be sold internationally to several countries in Asia and Africa. The previous formulation of the vaccine had to be kept frozen at −20ºC, causing practical challenges in the field.

This clinical trial implemented by the multi-disciplinary team at George Clinical compared the safety and immunogenicity of a new generation of ROTAVAC to the original formulation and also evaluated the non-interference of the new formulation with EPI vaccines.

The new generation has been optimally designed for ease of administration, reduced training requirements and a lower cold chain footprint. The new formulation can be refrigerated, resulting in significant savings in cold chain storage and distribution costs. The ROTAVAC 5C formulation now has the lowest cold chain footprint amongst rotavirus vaccine in the world.

George Clinical was selected for this contract based on a competitive quote, our reputation as a high quality provider and our bespoke solutions that focus on the customer’s specific needs. In addition, as a global provider of clinical research services, George Clinical already had ground personnel in Hyderabad and Bangalore to assist in services rendered including project management, clinical and medical monitoring, pharmacovigilance, data management, statistics and medical writing.