Title: “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” is ongoing at KEMHRC, Vadu.

Funder/ Sponsor: ICMR

Objective: The objectives of the study are to assess the IgA seroresponse and vaccine safety (reactogenicity, adverse events [AEs], and serious adverse events [SAEs]) in recipients of a mixed regimen of rotavirus vaccines (comprising of Rotavac and Rotasiil), compared to those receiving three doses of Rotavac and those receiving three doses of Rotasiil. The study is being undertaken at the behest of the Ministry of Health and Family Welfare, Government of India, in the national interest for identifying the safety and immunogenicity of two different types of licensed rotavirus vaccines, when administered interchangeably. These vaccines have already been rolled out through the national programs. Due to the availability of the aforementioned two vaccines in the country (Rotavac and Rotasiil), and the sociocultural reality that women move on to their paternal homes for childbirth and return to their in-laws‟ homes after a while, there remains a possibility of children receiving combination doses in the course of vaccination. The present concept proposal has been developed against this background to assess if a mixed vaccine regimen comprising of two antigenically distinct products would produce adequate immunological response and would remain safe. At the same time, as both the vaccines have been rolled out in national public health program, non-availability of one type may be supplemented with the other type at a particular time in the same dosing schedule, to avoid the delay or gap in the prescribed schedule.

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