> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/to-evaluate-safety-of-oral-cholera-vaccine-hillchol-bbv131-737dfcb7-9204-42c6-ab8a-5d522df26182 > Record changed: 2026-11-04 # To Evaluate Safety of Oral Cholera Vaccine Hillchol® (BBV131) NCT05732766 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) Participants 1,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) Lead sponsor Bharat Biotech International Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) Start date 2023-02-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) Number of sites 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) ## Title and summary **Summary** A Phase III randomized, modified double-blind, multi-centric, comparative study, to evaluate the non-inferiority of immunogenicity and safety of single strain oral cholera vaccine Hillchol® (BBV131) to the comparator vaccine Shanchol™ along with lot-to-lot consistency of Hillchol®(BBV131). Study Population: A total of 1800 participants will be enrolled in three descending age groups(Group I- ≥18, Group II: ≥5 to \\<18 and Group III: ≥1 to \\<5). In each group,600 participants will be enrolled and will receive two doses of Hillchol® (BBV131) vaccine two weeks apart. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) **Acronym** Hillchol131 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) **Short title** To Evaluate Safety of Oral Cholera Vaccine Hillchol® (BBV131) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) **Official title** A Phase III Randomized, Modified Double-blind, Multi-centric, Comparative Study, to Evaluate Non-inferiority, Immunogenicity and Safety Cholera Vaccine Hillchol® (BBV131) to the Comparator Vaccine Shanchol™ and Hillchol® Lot Consistency Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) ## Dates **Completion date** 2023-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) **First posted** 2023-02-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) **Registry last updated** 2023-02-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) **Primary completion date** 2023-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) **Start date** 2023-02-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) ## Size and sites **Participants** 1,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) **Planned participants** 1,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) **Number of sites** 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) **Lead sponsor** Bharat Biotech International Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) ## Identifiers **Registry ID** NCT05732766 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) **ClinicalTrials.gov ID** NCT05732766 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Prevention **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) ## Outcomes ### Primary outcomes 1. Immediate reaction Timeframe: Within 30 mins of administration of each dose Adverse reactions after administration of each dose 2. solicited adverse events Timeframe: 7-days Incidence, intensity, and the causality of all solicited adverse events during the 7-day follow up period after each dose. 3. unsolicited adverse events Timeframe: 7-days Incidence, intensity, and the causality of unsolicited adverse events during the 7-day followup period after each dose. 4. Serious Adverse Events (SAEs) Timeframe: V- :1Baseline (Day 0),V- 2: (Day 14+2),V-3: (Day 28+2),V- 4: (Day 56±7),V-5: (Day 90±7) and V- 6: (Day 180±7) Incidence, intensity, and the causality of all adverse events and Serious Adverse Events (SAEs) during the entire study period. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) ## Eligibility **Sex** All **Age groups** Children, Adults, Older adults **Minimum age** 1 Year **Maximum age** 99 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Participants /Legally acceptable representatives who have the ability to provide written informed consent. 2. Participants of either gender of age > 1 year. 3. Expressed interest and availability to fulfill the study requirements. 1. Willing to receive two doses of the vaccine at the specific study site. 2. Willing to be contacted on the phone to assess adverse events and for study reminders. 4. Agrees not to participate in another clinical study at any time during the study period. ### Exclusion criteria 1. Any history of anaphylaxis in relation to vaccination. 2. Participants with Immune function disorders including immunodeficiency diseases, or taking immunosuppressive/cytotoxic agents. 3. An individual is thought to have difficulty participating in the study due to severe chronic diseases, based on the judgment of the investigator. 4. Participants with 38℃ or higher body temperature measured within 24 hours or at the time of investigational product dosing. 5. Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours before study initiation 6. Diarrhea or administration of anti-diarrheal drugs or antibiotics to treat diarrhea within 1 week before study initiation. 7. Other vaccination within 4 weeks before study initiation. 8. Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months before study initiation. 9. Participation in another clinical trial. 10. History of cholera vaccinations or history of cholera diarrhea. 11. Pregnancy, lactation or willingness/intention to become pregnant during the study. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) ## Sites - King George Hospital, VisakhapatnamVisakhapatnam, IndiaNot yet recruiting - Rajarajeswari Medical College and HospitalKambīpura, IndiaNot yet recruiting - All India Institute of Medical Sciences, PatnaPatna, IndiaRecruiting - Pt BD Sharma,PGIMS/UHS. RohtakRohtak, IndiaRecruiting - Jeevan Rekha Hospital, BelgaumBelagavi, IndiaRecruiting - Gillurkar Multispecialty HospitalNagpur, IndiaRecruiting - Malla Reddy Narayana Multi Speciality HospitalHyderabad, IndiaNot yet recruiting - Rana Hospital Pvt LtdGorakhpur, IndiaRecruiting - New Leelamani Hospital Pvt LtdKanpur, IndiaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05732766) ## Related records ### Drugs (1) - Vibrio cholerae cvd 103-hgr strain live antigen ### Lead sponsors (1) - [Bharat Biotech International Limited](https://trialight.com/data/company/bharat-biotech-international-limited-b745e376-72b3-44b0-826c-e7782e2b0d85.md) ### Conditions (1) - [Cholera](https://trialight.com/data/condition/cholera-89395c52-b4b6-5929-ae68-d4505e355182.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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