Funding

Ministry of Health and Family Welfare, Government of India 

May 2018 – May 2020

₹ 57,600,000 (~US $ 850,000)

Project Brief

India’s Universal Immunization Programme has approved two indigenous rotavirus vaccines, Rotavac  and Rotasiil, to protect children from this severe diarrheal disease. This large, multicenter, six-armed Phase IV clinical trial was designed in response to a request from the Ministry of Health and Family Welfare to generate evidence on the safety and immune response of mixed vaccine regimens combining the two products. Enrolling nearly 2,000 infants across multiple sites, it stands among the largest immunogenicity studies of rotavirus vaccination ever conducted. The trial generated critical data which helped to inform national policy on vaccine interchangeability and program delivery, and eventually, supported the scaling up of the vaccine products nationally.

Role & Responsbilities

As a Co-Investigator, I contributed to the development of the study design, research protocol, statistical analysis plan, and data collection instruments. I coordinated regulatory submissions and communications with ethics committees, partner institutions, and national regulatory authorities, including the Clinical Trial Registry of India, the Data and Safety Monitoring Board, and the Drugs Controller General of India. I also managed the site team, overseeing training, field operations, and quality control, and participated in data interpretation and manuscript preparation. I led the conceptualization and implementation of this study from the beginning to the end.