Bharat Biotech completes oral cholera vaccine trials

Bharat Biotech completes oral cholera vaccine trials

Bharat Biotech on Wednes-day said its oral cholera vaccine (OCV) Hillchol has successfully completed phase III clinical trials.

The double-blind, ran-domised phase III clinical trial was to evaluate safety, immunogenicity, non-infe-riority and lot-to-lot consis-tency of single component of the OCV in comparison to a comparator vaccine (Shanchol) in a group of 1,800 individuals, from in-

fants to adults, across 10 clinical sites in India.

"Hillchol demonstrated a greater than 4-fold rise in vibriocidal antibodies against both Ogawa (68.3%) and Inaba (69.5%) serotypes, proving non-in-feriority to licensed vac-cines... supporting its po-tential as an effective OCV," Bharat Biotech said, on the study findings published in the Vaccine journal Scien-ceDirect. The trials pave way for distribution of Hill-chol within the next few months, the firm said.

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