Clinical trial NCT02164110: To Evaluate the Efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children
Official title: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prevention Harmful Effects
Lead sponsor: EuBiologics Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Instituto Universitario IVI
First posted: 2014-06-16
Enrollment: 3632
Sex: ALL
Minimum age (years): 1
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy
timeFrame: 14 days after second doses
measure: Safety
timeFrame: From first shot to 14 days after second dose
Secondary outcomes:
measure: Efficacy
timeFrame: 14 days after second doses
measure: Safety
timeFrame: From first shot to 14 days after second dose
measure: Efficacy
timeFrame: 14 days after second doses
measure: Safety
timeFrame: 14 days after second doses
Other outcomes:
Locations:
city: Quezon City
country: Philippines
facility: Antonio D. Ligsay, MD
Study officials:
affiliation: De La Salle University Hospital Medical Center
name: Roberto A. Espos, MD
role: PRINCIPAL_INVESTIGATOR
References: