Rotavirus Vaccine Interchangeability Trial

Immunogenicity and Safety of Rotavac® and Rotasiil® Administered in an Interchangeable Dosing Schedule among Healthy Indian Infants: A Multicentric, Phase IV, Open-Labeled, Randomized, Controlled Trial (RVICS)

Project Brief There are two rotavirus vaccines available through the public health system in India – Rotavac and Rotasiil. This study was conceptualized in response to the MOHFW’s request for evidence on what would happen if a child was to receive a mixed regimen comprising of the two vaccines. This study, a six-arm, multi-site trial, enrolling almost 2,000 children, is the largest immunogenicity study of children undergoing rotavirus vaccination in India
Principal Investigator Dr. Shanta Dutta, Scientist G and Director, ICMR-National Institute of Cholera and Enteric Diseases
My Role Co-Investigator

  • Development of protocol, data collection tools and other protocol-related documents
  • Project management and implementation, including trial-related regulatory activities
  • Development of data management and statistical analysis plan in collaboration with statistical team
  • Develop quality checks in collaboration with contract research organization (DiagnoSearch) overseeing the project implementation
  • Manage site team of 35 personnel, who reported to me on a daily basis.
Project Period May 2018 – October 2019
Funding Details Ministry of Health and Family Welfare, Government of India (MoHFW, GoI)

₹ 5.76 crore (~US $ 850,000)

More information CTRI/2018/08/015317

 

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