NCT02727855

Brief Summary

To evaluate the preventive impact, demand, acceptability, uptake, feasibility, and cost-effectiveness of a two-dose regimen of the OCV Shanchol in children living in urban slums in Bangladesh, Investigators will conduct a targeted mass immunization programme, using an innovative approach successfully deployed by the Bangladesh government in its recent countrywide campaign of MR vaccination of 52 million children aged 9 months to 14 years (\<15 years). Investigators will undertake a census of a geographic population of approximately 300,000 persons, with GIS locations of each household. This census will be updated every 6 months during the follow-up period to permit tracking of births, deaths, and migrations, including changes in location of each individual's residence. Following the initial census, the OCV will be offered to all non-pregnant individuals aged 1 to 14 years. Operational research and economic studies will evaluate the coverage, feasibility, acceptability, demand, costs and cost-effectiveness of this vaccination programme.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75,170

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

December 20, 2019

Status Verified

December 1, 2019

Enrollment Period

3.8 years

First QC Date

January 16, 2016

Last Update Submit

December 18, 2019

Conditions

Cholera

Keywords

CholeraVaccineStrategy

Outcome Measures

Primary Outcomes (1)

  • Number of participants with two doses of oral cholera vaccine (Shanchol) will get protection

    Shanchol vaccine will be given to healthy , non pregnant residents aged 1-14 years in Dhaka, Bangladesh against culture proven vibrio cholerae O1 diarrhoea which has been detected in all treatment settings serving the catchment population.

    2 years from dosing

Secondary Outcomes (4)

  • Cholera vaccine coverage

    10 months

  • Vaccine acceptability

    17 months

  • Vaccine feasibility

    17 months

  • Incidence of cholera among vaccinated individuals in vaccination area

    Two years after completion of vaccination

Interventions

ShancholBIOLOGICAL

Oral Cholera Vaccine

Eligibility Criteria

Age1 Year - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The study population will be recruited from different wards of Dhaka city corporation (wards 42, 43, 45, 46, 47, 48, 58, 91 and 92 which are now numbered as 29,30,32,33,34 of Dhaka North City Corporation and 14,22,55,56,57 of Dhaka South City Corporation respectively).

You may qualify if:

  • All healthy, consenting, non-pregnant (as ascertained by history) residents of a high risk group, 1 to 14 years of age, of the study area will be included in the study.

You may not qualify if:

  • Aged less than 1 year and more than 14 years
  • History of intake of any cholera vaccine
  • Pregnant women (identified through verbal screening)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, 1212, Bangladesh

Location

Related Publications (3)

  • Ali M, Lopez AL, You YA, Kim YE, Sah B, Maskery B, Clemens J. The global burden of cholera. Bull World Health Organ. 2012 Mar 1;90(3):209-218A. doi: 10.2471/BLT.11.093427. Epub 2012 Jan 24.

    PMID: 22461716RESULT

  • Sur D, Lopez AL, Kanungo S, Paisley A, Manna B, Ali M, Niyogi SK, Park JK, Sarkar B, Puri MK, Kim DR, Deen JL, Holmgren J, Carbis R, Rao R, Nguyen TV, Donner A, Ganguly NK, Nair GB, Bhattacharya SK, Clemens JD. Efficacy and safety of a modified killed-whole-cell oral cholera vaccine in India: an interim analysis of a cluster-randomised, double-blind, placebo-controlled trial. Lancet. 2009 Nov 14;374(9702):1694-702. doi: 10.1016/S0140-6736(09)61297-6. Epub 2009 Oct 8.

    PMID: 19819004RESULT

  • Glass RI, Becker S, Huq MI, Stoll BJ, Khan MU, Merson MH, Lee JV, Black RE. Endemic cholera in rural Bangladesh, 1966-1980. Am J Epidemiol. 1982 Dec;116(6):959-70. doi: 10.1093/oxfordjournals.aje.a113498.

    PMID: 7148820RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Specimens will be preserved for 5 years for future use.

MeSH Terms

Conditions

Cholera

Interventions

shanchol

Condition Hierarchy (Ancestors)

Vibrio InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Dr. Firdausi Qadri, PhD

    International Centre for Diarrhoeal Disease Research, Bangladesh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2016

First Posted

April 5, 2016

Study Start

January 1, 2016

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

December 20, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to anybody.

Locations

BA(1)