To Evaluate the Efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children
NCT02164110 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3632
Last updated 2014-12-08
Summary
The purpose of this study is to evaluate the efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children.
Conditions
- Prevention Harmful Effects
Interventions
- BIOLOGICAL
-
Euvichol
* Number of doses and intervals: two doses/Weeks 0 and 2 * Method of administration: oral administration * Dose of drug to be administered: 1.5 mL/dose
- BIOLOGICAL
-
Shanchol
* Number of doses and intervals: two doses/Weeks 0 and 2 * Method of administration: oral administration * Dose of drug to be administered: 1.5 mL/dose
Sponsors & Collaborators
-
Instituto Universitario IVI
collaborator OTHER -
EuBiologics Co.,Ltd
lead INDUSTRY
Principal Investigators
-
Roberto A. Espos, MD · De La Salle University Hospital Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Year
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-05-31
- Primary Completion
- 2014-09-30
- Completion
- 2014-10-31
Countries
- Philippines
Study Locations
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