Viewing Study NCT00128011



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Study NCT ID: NCT00128011
Status: COMPLETED
Last Update Posted: 2006-11-10
First Post: 2005-08-08

Brief Title: Safety and Immunogenicity of a New Formulation of a Bivalent Killed Whole-Cell Oral Cholera Vaccine
Sponsor: International Vaccine Institute
Organization: International Vaccine Institute

Study Overview

Official Title: A Safety and Immunogenicity Study of a New Formulation of the Locally-Produced Bivalent Killed Whole-Cell Oral Cholera Vaccine in Vietnamese Subjects
Status: COMPLETED
Status Verified Date: 2006-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to evaluate the safety and immunogenicity of a new formulation of a locally-produced bivalent O-1 and O-139 killed whole cell oral cholera vaccine among Vietnamese adults
Detailed Description: Cholera remains to be a serious public health problem worldwide In the mid-1980s following technology transfer from Sweden Vietnamese scientists developed and produced an oral killed monovalent cholera vaccine for Vietnams public health programs A 2-dose regimen of this vaccine has been shown to be safe and efficacious Subsequently a bivalent vaccine was developed containing the newly emergent O139 V cholerae This vaccine has several advantages over the existing Swedish vaccine It confers protection against the El Tor biotype in younger children is considerably less expensive does not require a buffer during administration and does not require strict cold chain requirements However this vaccine is not licensed for use in countries other than Vietnam In order to make this vaccine available to other countries the IVI has provided technical assistance to produce this vaccine following the WHO Good Manufacturing Practices standards A new formulation of the current oral cholera vaccine was produced following these guidelines Since this vaccine is slightly different from the previous vaccine a study is necessary to demonstrate safety and immunogenicity for local licensure and larger Phase III studies in other countries

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None