Hillchol (BBV131) / Hilleman Laboratories, Bharat Biotech - LARVOL DELTA

A double-blind, randomised phase III clinical trial to evaluate safety, immunogenicity, non-inferiority & lot to lot consistency of single component oral cholera vaccine BBV131 (Hillchol®) in comparison to Shanchol™. (PubMed, Vaccine) - "The findings indicate that BBV131 demonstrates non-inferior immunogenicity and comparable safety to Shanchol™ in healthy Indian adults and children, supporting its potential as an effective OCV."

Head-to-Head • Journal • P3 data • Cholera • Pain • Xerostomia

Oral killed cholera vaccines for preventing cholera. (PubMed, Cochrane Database Syst Rev) - "Two doses of Dukoral reduces cases of cholera at two-year follow-up. Two doses of Shanchol reduces cases of cholera at five-year follow-up, and a single dose of Shanchol reduces cases of cholera at two-year follow-up. Overall, the vaccines were safe and well-tolerated. We found no trials on other BivWC vaccines (Euvichol/Euvichol-Plus). However, BivWC products (Shanchol, Euvichol/Euvichol-Plus) are considered to produce comparable vibriocidal responses. Therefore, it is reasonable to apply the results from Shanchol trials to the other BivWC products (Euvichol/Euvichol-Plus)."

Journal • Review • Cholera • Infectious Disease

Hillchol131: To Evaluate Safety of Oral Cholera Vaccine Hillchol® (BBV131) (clinicaltrials.gov) - P3 | N=1800 | Recruiting | Sponsor: Bharat Biotech International Limited

Head-to-Head • New P3 trial • Cholera

A Phase III Randomized, Modified Double-blind, Multi-centric, Comparative Study, to Evaluate the Non-inferiority of Immunogenicity and Safety of Hillchol® (BBV131)to Shanchol™ Along With Lot-to-lot Consistency of Hillchol®(BBV131). (clinicaltrials.gov) - P3 | N=1800 | Active, not recruiting | Sponsor: Bharat Biotech International Limited

Head-to-Head • New P3 trial • Cholera