Single Dose Oral Cholera Vaccine Study in Dhaka, Bangladesh

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02027207
• Date of registration: 23/12/2013
• Prospective Registration: No
• Primary sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
• Public title: Single Dose Oral Cholera Vaccine Study in Dhaka, Bangladesh SCVB
• Scientific title: An Individually Randomized, Placebo-controlled Trial to Measure the Protection Conferred by a Single Dose Regimen of Bivalent, Killed, Whole Cell Oral Cholera Vaccine (Shanchol™) in Dhaka, Bangladesh
• Date of first enrolment: December 9, 2012
• Target sample size: 204438
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02027207
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Bangladesh

Key inclusion & exclusion criteria

Inclusion Criteria:

Healthy subjects > 1 year of age and above Living in high risk area for cholera Provision
of Informed consent for participating in the study by participant /parent or guardian as
well as verbal assent for children 11-17 years.

Exclusion Criteria:

Pregnant women Aged less than 1 year History of taking cholera vaccine



Age minimum: 1 Year
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cholera

Intervention(s)

Biological: Placebo

Biological: Shanchol

Primary Outcome(s)

Number of participants with a single dose regimen oral cholera vaccine Shanchol will get protection [Time Frame: 7 days to 6 months]

Secondary Outcome(s)

Number of participants with a single dose Shanchol with onset of 7 days to 6 months,7 days to 12 months, from 7 days to 18 months and 7 days to 24 months after dosing against acute watery diarrhoea detected in treatment centre [Time Frame: 7 days to 24 months]

Safety up to 28 days following a single dose of the bivalent, killed, whole cell oral cholera vaccine Shanchol™ administered to healthy, non-pregnant residents one year and older [Time Frame: 28 days]

Serum vibriocidal antibody responses to oral cholera vaccine Shanchol in healthy,non-pregnant residents, aged one year and older in a subset of population [Time Frame: 14 days]

Number of participants get protection with the single dose regimen of Shanchol against culture proven V. Cholerae O1 diarrhea with severe dehydration, V. Cholerae O139 diarrhea,V. Cholerae O139 diarrhea with severe dehydration . [Time Frame: 7 days to 24 months]

Number of participants get protection with a single dose Shanchol after dosing against culture-proven V. cholerae O1 diarrhea [Time Frame: 7 days to 24 months]

Number of participants with a single dose Shanchol with onset of 7 days to 6 months,7 days to 12 months, from 7 days to 18 months and 7 days to 24 months after dosing against acute watery diarrhea with severe dehydration detected in treatment centre [Time Frame: 7 days to 24 months]

Secondary ID(s)

PR-12090

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Government of Bangladesh

International Vaccine Institute