Cholera Clinical Trial
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
Verified date | November 2006 |
Source | International Vaccine Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Vietnam: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | June 2005 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Healthy non-pregnant adults - Available in the study area for 1 month Exclusion Criteria: - Diarrhea for the past week - Antibiotic use in the past week - Intake of anti-diarrheal medicines in the past week - One or more episodes of diarrhea or abdominal pain lasting for 2 weeks during the past 6 months - Abdominal pain, nausea, vomiting, loss of appetite or generalized ill feeling for the past 24 hours - Pregnancy |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Vietnam | National Institute of Hygiene and Epidemiology | Hanoi |
Lead Sponsor | Collaborator |
---|---|
International Vaccine Institute | Göteborg University, National Institute of Hygiene and Epidemiology, Vietnam |
Vietnam,
Anh DD, Canh do G, Lopez AL, Thiem VD, Long PT, Son NH, Deen J, von Seidlein L, Carbis R, Han SH, Shin SH, Attridge S, Holmgren J, Clemens J. Safety and immunogenicity of a reformulated Vietnamese bivalent killed, whole-cell, oral cholera vaccine in adult — View Citation
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Primary | Adverse events | |||
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