NCT00128011

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2005

Shorter than P25 for phase_2

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

May 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2005

Completed
Last Updated

November 10, 2006

Status Verified

November 1, 2006

First QC Date

August 8, 2005

Last Update Submit

November 8, 2006

Conditions

Cholera

Keywords

watery diarrheacholera vaccine

Outcome Measures

Primary Outcomes (2)

  • Adverse events

  • Serum Vibriocidal antibody response

Interventions

killed oral cholera vaccineBIOLOGICAL

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy non-pregnant adults
  • Available in the study area for 1 month

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Hygiene and Epidemiology

Hanoi, 10000, Vietnam

Location

Related Publications (1)

  • Anh DD, Canh DG, 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 adults. Vaccine. 2007 Jan 22;25(6):1149-55. doi: 10.1016/j.vaccine.2006.09.049. Epub 2006 Sep 29.

    PMID: 17055622RESULT

MeSH Terms

Conditions

Cholera

Condition Hierarchy (Ancestors)

Vibrio InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Dang Duc Anh, PhD

    National Institute of Hygiene and Epidemiology, Vietnam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2005

First Posted

August 9, 2005

Study Start

May 1, 2005

Study Completion

June 1, 2005

Last Updated

November 10, 2006

Record last verified: 2006-11

Locations

VN(1)