Trial | NCT02164110  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    3632
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 Started
May 31
2014
Primary Completion
Sep 30
2014
Study Completion
Oct 31
2014
Last Update
Dec 08
2014
Estimate

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

  • Other names: Oral Cholerae Vaccine

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

  • Other names: Oral cholera vaccine

Euvichol Experimental

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

Shanchol Active Comparator

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

Criteria 

Inclusion Criteria:

Written informed consent to study participation voluntarily provided by an individual or his/her legally acceptable representative.
Age of 1 ~ 40 years
An individual who can be followed up during the study period and is capable of complying with the study requirements.

Exclusion Criteria:

History of hypersensitivity reactions to other preventative vaccinations.
Immune function disorders including immunodeficiency diseases.
An individual thought to have difficulty participating in the study due to severe chronic diseases, based on the judgment of the investigator.
38℃ or higher body temperature measured prior to investigational product dosing.
Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours prior to study initiation.
Diarrhea or administration of antidiarrheal drugs or antibiotics to treat diarrhea within 1 week prior to study initiation.
Other vaccination within 1 week prior to study initiation or planned vaccination during the study.
Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study initiation.
Participation in another clinical trial with investigational product dosing within 1 month prior to study initiation.
Pregnant or lactating women.
An individual thought to have difficulty participating in the study due to other reasons, based on the judgment of the investigator
Applicable to the Pivotal study only: history of cholera vaccinations or history of cholera.
No Results Posted