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

December 4, 2014 updated by: EuBiologics Co.,Ltd

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

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

Study Overview

Status

Completed

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 Type

Interventional

Enrollment (Actual)

3632

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Quezon City, Philippines, 4332
        • Antonio D. Ligsay, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 38 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
  • 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
Active Comparator: 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
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: 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
14 days after second doses
Safety
Time Frame: 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)
From first shot to 14 days after second dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: 14 days after second doses
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
Safety
Time Frame: From first shot to 14 days after second dose
1. Change from baseline in vital signs and physical examination
From first shot to 14 days after second dose
Efficacy
Time Frame: 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).
14 days after second doses
Safety
Time Frame: 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.
14 days after second doses

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Roberto A. Espos, MD, De La Salle University Hospital Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

April 27, 2014

First Submitted That Met QC Criteria

June 12, 2014

First Posted (Estimate)

June 16, 2014

Study Record Updates

Last Update Posted (Estimate)

December 8, 2014

Last Update Submitted That Met QC Criteria

December 4, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • UBC301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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