The purpose of this study is to evaluate the efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children.
A randomized, single blind, multicenter, therapeutic confirmatory study to assess the efficacy (immunogenicity) and safety of Euvichol in healthy adults and children
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
3,632
* 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
* 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
Antonio D. Ligsay, MD
Quezon City, Philippines
Efficacy
Proportion of subjects exhibiting 4-fold or greater rises in titers of anti-V. cholera O1 antibody, relative to baseline
Time frame: 14 days after second doses
Safety
Type and frequency of solicited adverse event type (Day 0 \~ 6), Type and frequency of unsolicited adverse event type (Day 0 \~ Day 28)
Time frame: From first shot to 14 days after second dose
Efficacy
1\. Proportion of subjects exhibiting 4-fold or greater rises in titers of anti-V. cholera O139 antibody, relative to baseline
Time frame: 14 days after second doses
Safety
1\. Change from baseline in vital signs and physical examination
Time frame: From first shot to 14 days after second dose
Efficacy
1\. Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) as measured by each anti-V. cholera antibody titer at Week 2 (Visit 3) after the second dose as compared to prior to investigational product dosing (Visit 1).
Time frame: 14 days after second doses
Safety
1\. Change from baseline in laboratory tests (hematologic test, blood chemistry test, urinalysis) to be performed only in subjects who participate in the Pivotal study.
Time frame: 14 days after second doses
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