Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization

Summary

This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).

Timeline

Start

2015-11

Primary completion

2017-04

Completion

2017-06

Publications

• Results Desai S, Rathi N, Kawade A, Venkatramanan P, Kundu R, Lalwani SK, Dubey AP, Venkateswara Rao J, Narayanappa D, Ghildiyal R, Gogtay NJ, Venugopal P, Palkar S, Munshi R, Bavdekar A, Juvekar S, Ganguly N, Niyogi P, Uttam KG, Kondekar A, Kumbhar D, Mohanlal S, Agarwal MC, Shetty P, Antony K, Gunale B, Dharmadhikari A, Deshpande J, Nalavade U, Sharma D, Bansal A, Tang Y, Flores J, Kulkarni PS. Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL(R) with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine. Vaccine. 2018 Sep 5;36(37):5519-5523. doi: 10.1016/j.vaccine.2018.07.064. Epub 2018 Aug 10.

Drugs

Indications