Prevention Harmful Effects
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children.
Detailed description
A randomized, single blind, multicenter, therapeutic confirmatory study to assess the efficacy (immunogenicity) and safety of Euvichol in healthy adults and children
Interventions
BIOLOGICALEuvichol
* 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
BIOLOGICALShanchol
* 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
Instituto Universitario IVI
EuBiologics Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 14 days after second doses | Proportion of subjects exhibiting 4-fold or greater rises in titers of anti-V. cholera O1 antibody, relative to baseline |
| Safety | From first shot to 14 days after second dose | Type and frequency of solicited adverse event type (Day 0 \ 6), Type and frequency of unsolicited adverse event type (Day 0 \ Day 28) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 14 days after second doses | 1\. Proportion of subjects exhibiting 4-fold or greater rises in titers of anti-V. cholera O139 antibody, relative to baseline |
| Safety | From first shot to 14 days after second dose | 1\. Change from baseline in vital signs and physical examination |
Countries
Philippines
Outcome results
None listed