Bharat Biotech Oral Cholera vaccine Hillcholl shows success in Phase III studies
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-05-21 06:00 GMT | Update On 2025-05-22 01:52 GMT
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Hyderabad: Bharat Biotech's Oral Cholera Vaccine Hillchol has demonstrated against both Ogawa and Inaba serotypes, proving non-inferior in healthy Indian adults and children, supporting its potential as an effective OCV.
The above study findings have been published in the ScienceDirect, Vaccine journal 126998 to assess a double-blind, randomized phase III clinical trial to evaluate safety, immunogenicity, non-inferiority & lot-to-lot consistency of single component oral cholera vaccine Hillchol in comparison to a comparator vaccine in a diverse participant group of 1,800 individuals, from infants to adults, across 10 clinical sites in India.
In this study, participants were divided into three age groups: adults over 18 years, children aged 5 to under 18 years, and infants aged 1 to under 5 years. They were randomized in a 3:1 ratio to receive either Hillchol or a comparator vaccine.
The primary endpoint focused on the proportion of participants achieving >4-fold increase in vibriocidal antibody titres against Ogawa and Inaba serotypes 14 days after two doses. While secondary endpoints included Geometric Mean Titre (GMT) measurements and safety.
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