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

Prevention Harmful Effects Clinical Trial

Official title:

A Randomized, Single Blind, Multicenter, Therapeutic Confirmatory Study to Assess the Efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02164110
• Other study ID #: UBC301
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2014
• Last updated: December 4, 2014
• Start date: May 2014
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: EuBiologics Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines : Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children.

Description:

A randomized, single blind, multicenter, therapeutic confirmatory study to assess the efficacy (immunogenicity) and safety of Euvichol in healthy adults and children

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3632
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prevention Harmful Effects

Intervention

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
• 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

Locations

Country	Name	City	State
Philippines	Antonio D. Ligsay, MD	Quezon City

Sponsors (2)

Lead Sponsor	Collaborator
EuBiologics Co.,Ltd	Instituto Universitario IVI

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	Proportion of subjects exhibiting 4-fold or greater rises in titers of anti-V. cholera O1 antibody, relative to baseline	14 days after second doses	No
Primary	Safety	Type and frequency of solicited adverse event type (Day 0 ~ 6), Type and frequency of unsolicited adverse event type (Day 0 ~ Day 28)	From first shot to 14 days after second dose	Yes
Secondary	Efficacy	1. Proportion of subjects exhibiting 4-fold or greater rises in titers of anti-V. cholera O139 antibody, relative to baseline	14 days after second doses	No
Secondary	Safety	1. Change from baseline in vital signs and physical examination	From first shot to 14 days after second dose	No
Secondary	Efficacy	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).	14 days after second doses	No
Secondary	Safety	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.	14 days after second doses	No