NCT02164110

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,632 (actual)
• Sponsor: EuBiologics Co.,Ltd · Industry
• Sex: All
• Age: 1 Year – 40 Years
• Healthy volunteers: Accepted

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

Conditions

• Prevention Harmful Effects

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-09-01
• Completion: 2014-10-01
• First posted: 2014-06-16
• Last updated: 2014-12-08

Locations

1 site across 1 country: Philippines