To Evaluate the Efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children

Phase 3

Completed

• Conditions: Prevention Harmful Effects
• Interventions: Biological: Shanchol; Biological: Euvichol

• Registration Number: NCT02164110
• Lead Sponsor: EuBiologics Co.,Ltd

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

Study Timeline

• Study First Submitted: 2014-04-27
• Study Start: 2014-05
• Study First Submitted QC: 2014-06-12
• Study First Posted: 2014-06-16
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-04
• Last Update Posted: 2014-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3632

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shanchol	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
Euvichol	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Safety	14 days after second doses	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.
Efficacy	14 days after second doses	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).

Trial Locations

Locations (1)

Antonio D. Ligsay, MD; 🇵🇭 Quezon City, Philippines