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Mass Oral Cholera Vaccination in Zanzibar

NCT00709410 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51151

Last updated 2012-03-30

No results posted yet for this study

Summary

The purpose of this study is to conduct cholera vaccinations in high-risk populations in Zanzibar in order to estimate herd protection conferred by the vaccine,estimate effectiveness of the vaccine, and describe the interaction of vaccination and improved water supply on the burden of cholera and diarrhoeal diseases.

Conditions

Interventions

BIOLOGICAL

rBS-WC vaccine

1 mg of recombinant cholera toxin B subunit and approximately 1 x 10\^11 of inactivated whole cells of Vibrio cholerae O1 Inaba and Ogawa, classic and El Tor strains (6). The rBS-WC vaccine is supplied as 3 ml single-dose vials each with a sachet of sodium bicarbonate buffer. Buffer solution will be prepared by dissolving the sachets in drinking water (150 ml water for each sachet of sodium bicarbonate). The full dose of vaccine will be mixed with 40, 75, or 150 ml of buffer solution for persons 2 to 4 years, 5 to 11 years, and over 11 years old, respectively. The vaccine is recommended to be given in two doses with an interval of at least seven days and protection is conferred 7 to 10 days after the second dose.

Sponsors & Collaborators

  • Ministry of Health and Social Welfare, Zanzibar

    collaborator OTHER_GOV

  • National Institute of Cholera and Enteric Diseases, India

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • World Health Organization

    collaborator OTHER

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • Ahmed Khatib, MD · Ministry of Health and Social Welfare, Zanzibar

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-02-28
Completion
2011-12-31

Countries

  • Tanzania

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00709410 on ClinicalTrials.gov