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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02164110 |
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Date of registration:
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27/04/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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To Evaluate the Efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children
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Scientific title:
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A Randomized, Single Blind, Multicenter, Therapeutic Confirmatory Study to Assess the Efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children |
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Date of first enrolment:
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May 2014 |
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Target sample size:
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3632 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02164110 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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Philippines
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Contacts
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Name:
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Roberto A. Espos, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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De La Salle University Hospital Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Written informed consent to study participation voluntarily provided by an individual
or his/her legally acceptable representative.
2. Age of 1 ~ 40 years
3. An individual who can be followed up during the study period and is capable of
complying with the study requirements.
Exclusion Criteria:
1. History of hypersensitivity reactions to other preventative vaccinations.
2. Immune function disorders including immunodeficiency diseases.
3. An individual thought to have difficulty participating in the study due to severe
chronic diseases, based on the judgment of the investigator.
4. 38? or higher body temperature measured prior to investigational product dosing.
5. Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours prior to
study initiation.
6. Diarrhea or administration of antidiarrheal drugs or antibiotics to treat diarrhea
within 1 week prior to study initiation.
7. Other vaccination within 1 week prior to study initiation or planned vaccination
during the study.
8. Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study
initiation.
9. Participation in another clinical trial with investigational product dosing within 1
month prior to study initiation.
10. Pregnant or lactating women.
11. An individual thought to have difficulty participating in the study due to other
reasons, based on the judgment of the investigator
12. Applicable to the Pivotal study only: history of cholera vaccinations or history of
cholera.
Age minimum:
1 Year
Age maximum:
40 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Prevention Harmful Effects
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Intervention(s)
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Biological: Shanchol
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Biological: Euvichol
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Primary Outcome(s)
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Efficacy
[Time Frame: 14 days after second doses]
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Safety
[Time Frame: From first shot to 14 days after second dose]
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Secondary Outcome(s)
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Safety
[Time Frame: From first shot to 14 days after second dose]
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Safety
[Time Frame: 14 days after second doses]
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Efficacy
[Time Frame: 14 days after second doses]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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