Status:
COMPLETED
Bridging Study for Killed Oral Cholera Vaccine in Ethiopia
Lead Sponsor:
International Vaccine Institute
Collaborating Sponsors:
Armauer Hansen Research Institute, Ethiopia
Ministry of Health, Ethiopia
Conditions:
Vibrio Cholerae
Cholera
Eligibility:
All Genders
1+ years
Phase:
PHASE4
Brief Summary
This is a randomized, double blind, placebo controlled trial to confirm the safety and determine the immune response of the killed oral cholera vaccine in healthy adults and children in Ethiopia.
Detailed Description
This study serves as a bridging trial to evaluate the safety and immunogenicity of a two dose regimen of the WC-OCV (Shanchol®) in Ethiopian population. In order to assess whether the bivalent killed ...
Eligibility Criteria
Inclusion
- Male or female adults aged 18 years and above; and children aged 1 -17 years who is available for follow-up visits and specimen collection.
- The subject should be able to continue in the study for the next 4 weeks
- The subject (or parent/guardian) should be willing to provide 3 blood samples
- For females of reproductive age, non-pregnant (as determined by urine pregnancy test).
- Written informed consent obtained from the subjects or their parents/guardians, and written assent obtained from children aged 12 - 17 years.
- Healthy subjects as determined by:
- Medical history
- Physical examination
- Clinical judgment of the investigator
Exclusion
- Ongoing chronic recurring illness which may cause systemic symptoms as judged by the investigating physician.
- Ongoing acute illness.
- For females of reproductive age: Pregnancy (or females planning to become pregnant during the study period; as determined by verbal screening)
- Immunocompromising condition or on chronic systemic steroid therapy
- Diarrhea (3 or more loose/more watery stools within a 24-hour period) within 6 weeks prior to enrollment
- Intake of any anti-diarrhea medicine in the past week
- Abdominal pain or cramps, loss of appetite, nausea, or vomiting in the past 24 hours
- Temperature ≥38ºC (oral or axillary) warrants deferral of the vaccination pending recovery of the subject
- Previous hypersensitivity to formaldehyde.
- Receipt of immunoglobulin or any blood product during the past 3 months
- Receipt of oral cholera vaccine in the past three years
- Any potential subject currently participating or who will participate within the next six months in another clinical trial
- Positive screening urine pregnancy test for females greater than 12 years of age
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT01524640
Start Date
December 1 2012
End Date
August 1 2013
Last Update
May 4 2015
Active Locations (1)
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1
Armauer Hansen Research Institute
Addis Ababa, Oromiya, Ethiopia